Generated by All in One SEO v4.9.3, this is an llms.txt file, used by LLMs to index the site. # Niche - Clinical Research Organisation | Niche Science & Technology ## Sitemaps - [XML Sitemap](https://niche.org.uk/sitemap.xml): Contains all public & indexable URLs for this website. ## Posts - [News and comment](https://niche.org.uk/news-and-comment/) - [Medical Writing 2026: Adapting to AI and Rising Complexity](https://niche.org.uk/medical-writing-in-2026) - Explore how artificial intelligence, economic pressure, and regulation are transforming medical writing, and what this means for quality and accountability. - [The Future of Drug Development: Data, AI, and Clinical Trials by 2050](https://niche.org.uk/future-drug-development) - Explore how data, AI, and real-world evidence are transforming drug development and clinical trials, and what the pharma industry could look like by 2050. - [Is winning (that) important?](https://niche.org.uk/writing) - Metathesiophobia: from Preclinical to Clinical Development - [Ready, aim, fire!](https://niche.org.uk/targeting) - Metathesiophobia: from Preclinical to Clinical Development - [The Growing Role of Patient-Reported Outcomes in Clinical Study Reports](https://niche.org.uk/proscsr) - The world's first human COVID challenge trial has been given the green light - [MID-Frail Newsletter #7](https://niche.org.uk/mid-frail7) - Metathesiophobia: from Preclinical to Clinical Development - [Inside our Insider’s Insights](https://niche.org.uk/insiders3) - Metathesiophobia: from Preclinical to Clinical Development - [Increasing Complexity of Clinical Study Reports](https://niche.org.uk/increasingcsr) - The world's first human COVID challenge trial has been given the green light - [The Investigator’s Brochure: Multifaceted and multidisciplinary](https://niche.org.uk/ib) - Metathesiophobia: from Preclinical to Clinical Development - [Revised FIH EMA Guideline: Opinion reported](https://niche.org.uk/eufemed3) - The EUropean Federation for Exploratory MEdicines Development (EUFEMED - [Revised FIH EMA guideline: Disruptive or constructive?](https://niche.org.uk/eufemed2) - The EUropean Federation for Exploratory MEdicines Development (EUFEMED - [Clinical study reports under the microscope](https://niche.org.uk/csr1) - Metathesiophobia: from Preclinical to Clinical Development - [The 10 best science presents… ...ever?](https://niche.org.uk/christmas5) - Metathesiophobia: from Preclinical to Clinical Development - [Season’s greetings for 2014 and best wishes for the year to come](https://niche.org.uk/christmas3) - With the year coming to a close, the Niche team are eager to thank all our colleagues - [Thanks for all your involvement in 2013 and our hopes for 2014](https://niche.org.uk/christmas2) - With the year coming to a close, the Niche team are eager to thank all our colleagues - [Season’s greetings, thanks for all your involvement in 2012 and things to come](https://niche.org.uk/christmas1) - With the year coming to a close, the Niche team are eager to thank all our colleagues - [Pulling the pin...](https://niche.org.uk/business5) - Metathesiophobia: from Preclinical to Clinical Development - [Challenge trials: What you need to know](https://niche.org.uk/challenge2) - The world's first human COVID challenge trial has been given the green light - [Regulating medical devices in the event of a no deal scenario](https://niche.org.uk/brexit4) - Metathesiophobia: from Preclinical to Clinical Development - [That’s all folks!](https://niche.org.uk/death1) - In 1786, estimates placed our average life expectancy at just 24 years. - [Toot your horn...](https://niche.org.uk/toot) - People working in the sciences aren’t generally perceived as being outgoing. - [Creating awesome titles](https://niche.org.uk/titles2) - Creating an awesome title is like bending a straight line into a circle. - [Investigator-Initiated Clinical Trials](https://niche.org.uk/sites32) - Investigator-Initiated Clinical Trials (IITs) are clinical studies led by academic researchers or clinicians - [Site selection - getting it right](https://niche.org.uk/sites) - High functioning investigator sites are essential to the delivery - [Handling rejection](https://niche.org.uk/rejection) - Occasionally, a manuscript will be accepted on first submission without revisions. - [Quality control tips when reviewing clinical study reports](https://niche.org.uk/qualitycsr) - Once all the subjects have gone home, the samples have been analysed, - [Eight tips for writing a press release](https://niche.org.uk/press) - At some point, you'll want to share your great projects with your friends - [Creating your best presentation (ever)](https://niche.org.uk/presentations2) - We wanted to tell you about our latest Insider’s Insight - Ta dah - [Be the cool kid at congress....](https://niche.org.uk/posters) - Posters are an excellent opportunity to showcase your work - [Good but not original!](https://niche.org.uk/plagiarism) - Plagiarism is an issue of growing concern within the scientific literature - [Top 10 tips to writing up your PhD](https://niche.org.uk/phd) - Writing your PhD thesis can be a once-in-a-lifetime opportunity - [Love: an AI's inquiry into the essence of human connection](https://niche.org.uk/love2) - We recently encouraged writers (of all kinds) in our recent Insider’s Insight to experiment with large language artificial intelligence (AI) models when drafting their documents - [The undiscovered country](https://niche.org.uk/literature) - The scientific literature comprises scholarly publications that report original - [Conducting effective literature searches](https://niche.org.uk/lit-searches) - Searching the literature can take various forms, ranging from a quick scan of recent publications - [Looking out for a hero…](https://niche.org.uk/kols) - We all need heroes - people who can champion our cause - helping the world to understand our rationale - [Ready! Aim! Fire!](https://niche.org.uk/journals) - Since 2013 we have been sharing our understanding on key issues with friends and clients via our Insider’s Insights. - [Shorter titles get more citations](https://niche.org.uk/insiders55) - Titles are the first thing readers see, yet often they are addressed - [Coming to a consensus](https://niche.org.uk/consensus) - Clinical consensus statements are agreed opinions formulated by a group of experts - [Rediscovering case reports](https://niche.org.uk/casereports) - Have you seen our latest Insider's Insight on Case Reports? Once a staple of medical journals, - [Awesome advisory boards](https://niche.org.uk/adboard) - Advisory board meetings are often used to address perceived knowledge gaps and build consensus. - [Did you miss this...?](https://niche.org.uk/bibs) - Did you miss our Insider's Insight into understanding the complex world of bibliometrics [1]? - [Killing predatory journals…](https://niche.org.uk/bibliometrics2) - We all get them, some of us more than 10 a day, emails from journals - [Baffling bibliometics](https://niche.org.uk/bibliometrics) - The prestige of publication has been based on traditional citation metrics - [Awesome abstracts](https://niche.org.uk/abstracts) - You may think that 'writing the abstract' simply involves summarising - [20 years ago, today…](https://niche.org.uk/20years) - When I was younger, the opening lines of the Beatle’s seminal ‘Sgt. Pepper’s Lonely Hearts Club Band’ resonated with a sense of genuine nostalgia, which was most likely what Messrs Lennon and McCartney had intended. - [Honorary Fellowship](https://niche.org.uk/sites3) - Congratulations class of 2024. That was all I needed to hear when I stood in your shoes almost 40 years ago. 40 years - [Tis the season to be sciencey... fa-la-la-la-laa…](https://niche.org.uk/xmas8) - The festive season is upon us again. - [Phase 1’s future in the UK](https://niche.org.uk/phase1) - Phase I is the lifeblood or new medicines. The UK’s Phase I representative body, - [Paraskevidekatriaphobia or triskaidekaphobia](https://niche.org.uk/13th) - Paraskevidekatriaphobia is a phobia of Friday the 13th. Yes, they actually gave it a name. - [Hiding not learning](https://niche.org.uk/conference2) - I have never been great at conferences. People don’t believe me but I am painfully shy and far too worried about what people think of me. - [Clinical Trials Day 2023 – Banging!](https://niche.org.uk/music2) - Whether it’s a festival, concert or celebratory party, music unites people and pervades - [Clinical Trials Day 2023 – Relax!](https://niche.org.uk/music) - Music has a remarkable ability to bring people together and permeate - [Writing: five deadly sins and a medley of damning habits](https://niche.org.uk/editing) - Scientific knowledge should be accessible to all and if you are those communicating science - [Top tips for investigator site selection](https://niche.org.uk/sites2) - Investigator sites are very important to clinical studies because they make sure that new drugs are safe and work well. - [Feeling the fourth on Star Wars Day](https://niche.org.uk/starwars3) - Yes, it’s Star Wars Day again! The Star Wars films base their wow-factor on their adoption of science - [Combating mediocrity](https://niche.org.uk/mediocrity) - Perhaps one of the greatest challenges we have faced over the last 25 years - [Data, data everywhere… far too much to think](https://niche.org.uk/data) - Every year, a huge amount of scientific data is released. It's out there, but how do you find it? - [Good Laboratory Practices?](https://niche.org.uk/glp) - Do you know what Good Laboratory Practice stands for? In nonclinical animal studies - [April Fools](https://niche.org.uk/fools) - By their very nature, experts don't find humour funny. We take things way too literally. - [Mandatory adoption of the European Clinical Trials System approaches](https://niche.org.uk/ctis) - Concerns about readiness of the European Medicines Agency’s (EMA) Clinical Trials Information System persist as the deadline for compliance arrives. - [iOnctura's Innovation Passport](https://niche.org.uk/ilap) - The clinical stage biotechnology company developing breakthrough therapies for patients suffering with cancer, - [Metathesiophobia: from preclinical to clinical development](https://niche.org.uk/metathesiophobia1) - Having worked in early-stage clinical pharmacology for over 30 years - [Top 10 horrifying Halloween healthcares](https://niche.org.uk/halloween7) - I've been studying medicine for 40 years, and it's beginning to look like something out of science fiction - [E-mail: the (new) gender battleground](https://niche.org.uk/email) - The internet was set alight last week on the issue of differences in the approach to emails adopted by men and women. - [Graduation Day](https://niche.org.uk/graduation) - Son, I wanted to record this landmark day in your progress through life. - [Father's Day](https://niche.org.uk/dads) - I am continually reminded that I must work toward better relationships with my sons than the one I had with my dad. - [Exacerbation and risk factors in severe asthma](https://niche.org.uk/asthma4) - Asthma is a chronic inflammatory disorder of the airways - [Impact of the COVID-19 pandemic on clinical trial conduct](https://niche.org.uk/covid) - Early in 2020, COVID-19 was spreading rapidly across the globe. - [Love pharmacology](https://niche.org.uk/love3) - We have long been confounded by that indescribable phenomenon known as love. - [Insights from the human COVID-19 challenge study](https://niche.org.uk/challenge) - The UK's world-class human challenge study gives us new information about SARS-CoV-2 cases that were mild in 36 healthy young volunteers who were not immune to the virus - [Fireworks](https://niche.org.uk/fireworks) - I love this time of year because I love fireworks. Did a love of fireworks spark a lifelong interest in science? When I was about 11, a close friend showed me fireworks for the first time. - [Understanding your fears](https://niche.org.uk/halloween3) - In the past, Halloween has meant the end of the crop and the start of the dark, cold winter. - [How frights create a happy Halloween](https://niche.org.uk/halloween2) - Frights create a happy Halloween by providing the thrill of fear in a controlled and safe environment, turning what would normally be unsettling or terrifying into something fun and enjoyable. - [Rational Vaccines wins MHRA ILAP passport](https://niche.org.uk/ratvac) - Rational Vaccines (RVx) announces MHRA Innovation Licensing and Access Pathway (ILAP) approval for their live attenuated vaccine candidate for herpes. - [A simple polymeric small molecule from the 70's versus COVID-19?](https://niche.org.uk/azb) - There have been hundreds of thousands of deaths from COVID-19 - [Home working charter for medical communications](https://niche.org.uk/survey2) - Work never stops and after the findings of our ground breaking survey in the EMWA - [A survey to inform working practices](https://niche.org.uk/survey3) - The sudden imposition of remote working in response to the 2020 COVID-19 - [Will you be frail in old age?](https://niche.org.uk/ageing) - Phenotype-specific omic expression patterns in people with frailty could provid - [Update on the Investigator's Brochure](https://niche.org.uk/ib2) - There are many regulatory documents but perhaps none are more critical - [Type 2 dipeptidyl peptidase‐4 inhibitors, SARS‐CoV‐2 and cockroaches](https://niche.org.uk/dpp4) - The comparison of the DPP4 (dipeptidyl peptidase 4) SARS-CoV-2 - [2020 Best of the Best](https://niche.org.uk/xmas6) - Here are a few lists of the best of the best over the last 12 months. - [Nap Attack!](https://niche.org.uk/nap) - The US Army has a new secret weapon – napping. - [I love it when a plan...](https://niche.org.uk/plan2) - In this case the plan is a paradigm shift in the way we will manage - [Deep Breath: Issue #8](https://niche.org.uk/rasp8) - All of our core studies have now completed their clinical phase - [Sports Survey](https://niche.org.uk/survey) - When the UK went into lockdown on March 23rd because of the COVID-19 outbreak, - [Milestones](https://niche.org.uk/sarcoid1) - As a jobbing scientist you rarely spend your whole career working on the same project. - [Mental health and remote working](https://niche.org.uk/remote-working) - At the start of the year many of us faced changes to the way we work as the COVID-19 - [Bad News Event Horizon](https://niche.org.uk/news) - When a country’s economy becomes so dominated by a single export industry - [5 tips for Star Wars Day](https://niche.org.uk/starwars2) - May 4 is often known as ‘Star Wars Day’. It is jokingly said - [Ten tips for promoting your research](https://niche.org.uk/targeting2) - Finding the best vehicle in which to publish your research findings is a perennial challenge. - [A year in review (2019)](https://niche.org.uk/2019) - Over the years friends, colleagues and industry leaders have shared their many of their insights with me freely - [Clinical pharmacologists prepare for change](https://niche.org.uk/eufemed1) - The latest issue of Journal Frontiers in Pharmacology has just published - [Halloween!](https://niche.org.uk/halloween) - Halloween is upon us again. - [The future for clinical studies](https://niche.org.uk/future) - Attend any research meeting, conference or clinical congress - [Deep Breath: Issue #7](https://niche.org.uk/rasp7) - Welcome to the seventh issue of the Refractory Asthma Stratification Programme (RASP-UK) newsletter - [Our infinite monkey cage](https://niche.org.uk/students) - We all have a responsibility to encourage young people to study science - [Infinite Monkey Cage](https://niche.org.uk/training) - We should all do what we can to get young people interested - [Science won’t save medicine](https://niche.org.uk/bps) - Last night saw a collection of the UK’s great and the good in clinical pharmacology - [A EUFEMED achievement](https://niche.org.uk/eufemed) - I'm sure that everyone works hard and tries to do their best. - [Multimodal intervention in functionally impaired older people](https://niche.org.uk/multimodal) - Our publication on effectiveness of a multimodal intervention - [Coming of age](https://niche.org.uk/business6) - We use the term coming of age to describe the transition into adulthood - [Website for the Clinical Trials Specialist Degree Apprenticeship goes live](https://niche.org.uk/apprenticeship) - Visit our brand-new website to learn more about our innovative training programme - [UK – Doing OK](https://niche.org.uk/brexit6) - One notable characteristic of Brexit has been a race for the bottom by journalists - [Lipid milestone](https://niche.org.uk/lipid) - ive years ago I was lucky enough to be involved in a project that resulted in publications - [Mapping non-adherence and airway inflammation in managing severe asthma](https://niche.org.uk/asthma1) - Because new biologic treatments for asthma can be expensive and cause side effects, - [Expanded ‘No-Deal’ Brexit preparations for pharmaceuticals and medical devices](https://niche.org.uk/brexit) - However you may feel about the way political leaders have turned Brexit - [The 12 best science presents…...ever?](https://niche.org.uk/xmas) - The festive season is a time for the giving and receiving of gifts. - [Association for Human Pharmacology in the Pharmaceutical Industry](https://niche.org.uk/ahppi1) - The proceedings of the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI) - [Stay happy](https://niche.org.uk/happy) - Last week marked 12 months since I was involved in a life-changing accident. - [Six hard questions](https://niche.org.uk/business2) - In response to my post with tips for people who want to start their own business - [Top 6 tips when starting a company](https://niche.org.uk/business1) - Last week was the 20-year anniversary of my founding Niche Science & Technology Ltd. - [Bigger on the inside](https://niche.org.uk/insiders) - I am shamelessly referencing our Insider’s Insights (IIs) to Dr Who’s TARDIS – our latest edition - [Top 5 reasons why bigger isn’t (always) better](https://niche.org.uk/bigger) - The largest pharmaceutical companies not surprisingly rely on the largest contract research organizations - [Wormy secrets to longer life](https://niche.org.uk/worms) - Research into the remarkable regenerative powers of the flatworm Macrostomum lignano a - [Deep Breath: Issue #6](https://niche.org.uk/rasp6) - It was encouraging to see so many partners at the 2017 General Assembly meeting last December - [300 standards and counting…](https://niche.org.uk/apprenticeship2) - The Institute for Apprenticeships (IFA) has approved its 300th - [Titanic clinical protocols](https://niche.org.uk/protocols) - Experience at Niche has taught us that clinical study protocols are born in the white-hot fire - [Critically thinking](https://niche.org.uk/critical-thinking) - Today my son has taken his GCSE exam in Critical Thinking. - [Pharma – newbies trailblazing the future](https://niche.org.uk/newbies) - Our team are exploring different and novel ways for young people to enter the pharmaceutical industry. - [Star Wars Day](https://niche.org.uk/starwars) - On this day 2 years ago I had a pretty bad accident getting knocked off my motorbike - [Business learnings: 20 years – 20 tips](https://niche.org.uk/business4) - The last 20 years at Niche have been amazingly exciting – offering - [Three business starter survival traits](https://niche.org.uk/business) - Yesterday was 20 years since the Memorandum - [Keep it brief…](https://niche.org.uk/brevity) - Never judge a book by its cover –we know - [From a father to his son...](https://niche.org.uk/fatherson) - on the occasion of your becoming an adult. - [Conference organising 101](https://niche.org.uk/conference) - They say that as one door closes another one opens. - [A thoughts trip through the brain](https://niche.org.uk/brain) - It is possible to use electrodes to record brain - [A great disturbance in the force](https://niche.org.uk/wolff) - Heinz Siegfried Wolff, scientist and broadcaster, born 29 April 1928 - [Humbled - try it!](https://niche.org.uk/humble) - My end-of-year task for yesterday was a visit the local police station - [Developing medical devices to help manage chronic respiratory conditions](https://niche.org.uk/aim1) - Academic Industry Meeting days (AIMdays) - [Top 5 leadership lessons from death](https://niche.org.uk/death2) - This is me, close to death – again. - [Targeting death](https://niche.org.uk/death) - Many of the increasing number of elderly in our population - [Super-ageing takes guts](https://niche.org.uk/superage) - We are looking over the precipice that is a revolution - [Deep Breath Issue #5](https://niche.org.uk/rasp5) - RASP-UK underwent its third progress review by the MRC on 19 May. - [Immortality – no thanks!](https://niche.org.uk/old3) - We are looking over the precipice that is a revolution in lifespan modification. - [Can we stop ageing?](https://niche.org.uk/old5) - According to many observers we are standing on the precipice - [Are you old?](https://niche.org.uk/old) - Ask anyone and they will tell you that they don’t think they are as old as they are. - [Tantalising telomeres](https://niche.org.uk/aging4) - Many scientists believe that we have reached the end of the life-expectancy revolution - [Deep Breath Issue #4](https://niche.org.uk/rasp4) - Welcome to the latest issue of the Refractory Asthma Stratification Programme (RASP-UK) - [Age 40 years in 5 minutes...](https://niche.org.uk/age13) - With age comes wisdom, however the physical side of ageing - [Frailomic Newsletter #8](https://niche.org.uk/frailomic8) - Welcome to the latest edition of the Frailomic Initiative Newsletter. - [Asthma UK discusses RASP-UK](https://niche.org.uk/rasp13) - In its recent white paper on severe asthma, The Severe Asthma Report 2017 - [12 Days of Nichemas](https://niche.org.uk/nichemas2) - Since 2013, our Insider's Insights have been a way for Niche - [Coming soon - 12 Days of Nichemas](https://niche.org.uk/nichemas) - Did we mention that we love to share? We post news about science - [Calling postdocs](https://niche.org.uk/postdoc) - It can feel like a career in science is about sacrifice. - [Deep Breath: Issue #3](https://niche.org.uk/rasp3) - Download the third issue of the Refractory Asthma Stratification - [Frailomic and MID-Frail (Newsletter #9)](https://niche.org.uk/frail-mid-frail9) - Read the latest newsletter here [1]. In this edition - [Frailomic Newsletter #7](https://niche.org.uk/frailomic7) - Welcome to the Frailomic Newsletter Update for 2016. - [Mentoring – what’s the buzz?](https://niche.org.uk/mentoring) - Want a conversation to warm your heart and lift your spirits - [Thanks for all the fun – Niche anniversary](https://niche.org.uk/niche) - I was planning to post an article on mentorship today - [Making better PowerPoint presentations](https://niche.org.uk/powerpoint) - We are sharing our latest Insider’s Insight – Ta dah - [Love or passion?](https://niche.org.uk/love1) - It the time of school retrospectives once again - [Deep Breath: Issue #2](https://niche.org.uk/rasp-uk-newsletter2) - Welcome to the second issue of the Refractory Asthma Stratification - [Living longer in good health](https://niche.org.uk/ageing7) - Unfortunately, health does not generally improve with age. - [Cast your bread upon the waters](https://niche.org.uk/alive2) - Even though I'm not particularly religious - [Great to be alive - Thank you](https://niche.org.uk/alive) - At a time when the news seems to enjoy focusing on bad things - [RASP-UK on World Asthma Day 2016](https://niche.org.uk/rasp12) - World Asthma Day was first launched in 1998 - [Deep Breath: Issue #1](https://niche.org.uk/rasp-uk-newsletter1) - Deep Breath is the official newsletter of the UKs Refactory Asthma - [Deceiving your brain: Why April Fools Day pranks work](https://niche.org.uk/april-fools) - There is something about primeval about the part of human - [Frailomic and MID-Frail newsletters (#8 and #6)](https://niche.org.uk/frail-mid-frail) - Read the latest newsletter from both our MID-Frail - [Best presents go beyond the 'big reveal'](https://niche.org.uk/lastchristmas) - Buying Christmas presents for people can be difficult - [Season’s greetings for 2015 and best wishes for the year to come](https://niche.org.uk/christmas4) - With the year coming to a close, the Niche team - [Five reasons why abstracts are important](https://niche.org.uk/abstracts1) - There is a short summary of a scientific paper called an abstract - [Guideline update for communicating company-sponsored research (GPP3)](https://niche.org.uk/gpp3) - A new guidance document for the publication of company-sponsored - [Typing two spaces...](https://niche.org.uk/mw1) - There are people everywhere who use two spaces after a full-stop. - [Issue #9 of our Insider's Insights](https://niche.org.uk/insiders9) - We've been sharing you our Insider's Insights with you for 2 years now. - [Bariatric surgery in obese older people: useful or not?](https://niche.org.uk/bariatric-surgery) - Our publication on the potential benefits of bariatric surgery - [First RASP-UK publication](https://niche.org.uk/rasp-uk-pub1) - The first publication to come out of our UK Refractory Asthma - [Frailomic Newsletter #5](https://niche.org.uk/frailomic5) - We have just released our latest Frailomic consortium - [Avoidable mistakes when planning your clinical trial](https://niche.org.uk/clinops) - Clinical trials are not cheap to conduct, and with data integrity - [A new Medical Research Council-funded asthma research programme](https://niche.org.uk/rasp1) - Our group of academic and industry partners won a big MRC grant yesterday - [Frailomic newsletter #4](https://niche.org.uk/frailomic4) - In the UK we have a saying that you wait hours for a bus and then two come along at once. - [MID-Frail newsletter #6](https://niche.org.uk/midfrail6) - This essential reading provides readers with a round-up of news on the latest events - [Third Frailomic consortium newsletter](https://niche.org.uk/frailomic3) - You can now download our latest newsletter, detailing how 2014 - [Sarcoidosis: Epidemiological and aetiological links](https://niche.org.uk/sarcoid) - Our publication on sarcoidosis, a multisystem inflammatory disease - [On your marks… we’re about to SPRINTT](https://niche.org.uk/sprintt) - Frailty has a dramatic impact on the quality of life of many elderly people - [Unknown knowns](https://niche.org.uk/english) - We have some strange terms in the pharma industry - [Project Tracking: A valued tool for multiple multidisciplinary projects](https://niche.org.uk/project-tracking) - If you're managing a project, it's important to stay informed about work progress - [Second Frailomic consortium newsletter](https://niche.org.uk/frailomic2) - The coming year is expected to be a very productive year for the consortium - [The fifth MID-Frail newsletter](https://niche.org.uk/mid-frail5) - The New Year started excellently for MID-Frail with the first patients - [The fourth MID-Frail newsletter](https://niche.org.uk/mid-frail4) - We are pleased to bring you the latest edition of the MID-Frail newsletter - [New therapies in the management of type 2 diabetes mellitus](https://niche.org.uk/new-t2dm) - Our publication on new therapies in the management of type 2 diabetes mellitus - [New therapies to reduce low-density lipoprotein cholesterol](https://niche.org.uk/new-ldl) - ur publication on new therapies to reduce low-density - [Applying the right layout to your poster](https://niche.org.uk/poster-layout) - Know the difference between an eye-catching, action-inspiring poster - [First Frailomic consortium newsletter](https://niche.org.uk/frailomic1) - Welcome everyone to the first issue of the Frailomic consortium - [The real thing](https://niche.org.uk/real-thing) - sA lot of people say that people don't just buy things, they buy connection - [FRAILOMIC initiative awarded 7th Framework approval](https://niche.org.uk/frailomic-approval) - Niche Science & Technology are playing a key role in the Frailomic project - [New MID-Frail Consortium Newsletter](https://niche.org.uk/mid-frail) - 2012 has been a very busy year for the MID-Frail partners and the study consortium - [Talking sense about science](https://niche.org.uk/talking-sense) - I believed that the central purpose of journalism is to provide the general population - [Female urinary incontinence](https://niche.org.uk/urinary-incontinence) - Our publication on the use of cardiovascular medication in women and continence - [New lipid-lowering drugs: an update](https://niche.org.uk/lipid-lowering) - The progression of atherosclerosis, which is responsible for coronary heart disease - [Grünenthal, maker of thalidomide, issues an apology after 50 years](https://niche.org.uk/thalidomide) - If you have been involved in the pharmaceutical industry for any length - [Efficient manuscript editing using a three-phase workflow](https://niche.org.uk/manuscript-editing) - You can waste a considerable amount of time when reviewing and editing - [PCSK-9 as a treatment for hyperlipidaemia](https://niche.org.uk/pcsk9) - Today we had our manuscript on the pre-protein convertase subtilisin kexin (PCSK)-9 - [New MID-Frail Consortium Newsletter #2](https://niche.org.uk/mid-frail-newsletter-2) - MID‐Frail News returns with this Special Issue to report on the project development - [MID-Frail Consortium Newsletter #1](https://niche.org.uk/mid-frail-newsletter1) - Welcome to the first issue of the MID‐Frail newsletter - [Editing tip: Size is important](https://niche.org.uk/size-is-important) - Writing that is short is vigorous. - 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Urinary retinol-binding protein (RBP) excretion and erythrocyte sodium-lithium countertransport (SLC) activity in a cohort of healthy normotensive subjects - [Contribution of nucleoside analogue reverse transcriptase inhibitors to subcutaneous fat wasting in patients with HIV infection](https://niche.org.uk/publications/contribution-of-nucleoside-analogue-reverse-transcriptase-inhibitors-to-subcutaneous-fat-wasting-in-patients-with-hiv-infection/) - Contribution of nucleoside analogue reverse transcriptase inhibitors to subcutaneous fat wasting in patients with HIV infection - [Effects of lipids in patients with familial hypercholesterolaemia on the kinetics of the sodium-lithium countertransporter](https://niche.org.uk/publications/effects-of-lipids-in-patients-with-familial-hypercholesterolaemia-on-the-kinetics-of-the-sodium-lithium-countertransporter/) - Effects of lipids in patients with familial hypercholesterolaemia on the kinetics of the sodium-lithium countertransporter - [The QUEST trial, a paradigm of HIV collaborative research](https://niche.org.uk/publications/the-quest-trial-a-paradigm-of-hiv-collaborative-research/) - The QUEST trial, a paradigm of HIV collaborative research - [Brain and CSF entry of the novel non-nucleoside reverse transcriptase inhibitor, GW420867X](https://niche.org.uk/publications/brain-and-csf-entry-of-the-novel-non-nucleoside-reverse-transcriptase-inhibitor-gw420867x/) - Brain and CSF entry of the novel non-nucleoside reverse transcriptase inhibitor, GW420867X - [Relation between sodium-lithium countertransport and hypertriglyceridemia in type V hyperlipidemia](https://niche.org.uk/publications/relation-between-sodium-lithium-countertransport-and-hypertriglyceridemia-in-type-v-hyperlipidemia/) - Relation between sodium-lithium countertransport and hypertriglyceridemia in type V hyperlipidemia - [Pharmacokinetics and safety of escalating single and repeat oral doses of GW420867X, a novel non-nucleoside reverse transcriptase inhibitor](https://niche.org.uk/publications/pharmacokinetics-and-safety-of-escalating-single-and-repeat-oral-doses-of-gw420867x-a-novel-non-nucleoside-reverse-transcriptase-inhibitor/) - Pharmacokinetics and safety of escalating single and repeat oral doses of GW420867X, a novel non-nucleoside reverse transcriptase inhibitor - [The current status of antihypertensive treatments: into the new millennium](https://niche.org.uk/publications/the-current-status-of-antihypertensive-treatments-into-the-new-millennium/) - The current status of antihypertensive treatments: into the new millennium - [The bioavailability of the novel nonnucleoside reverse transcriptase inhibitor GW420867X is unaffected by food in healthy male volunteers](https://niche.org.uk/publications/the-bioavailability-of-the-novel-nonnucleoside-reverse-transcriptase-inhibitor-gw420867x-is-unaffected-by-food-in-healthy-male-volunteers/) - The bioavailability of the novel nonnucleoside reverse transcriptase inhibitor GW420867X is unaffected by food in healthy male volunteers - [Changes in referral patterns to cardiac out-patient clinics with ambulatory ECG monitoring in general practice.](https://niche.org.uk/publications/changes-in-referral-patterns-to-cardiac-out-patient-clinics-with-ambulatory-ecg-monitoring-in-general-practice/) - Changes in referral patterns to cardiac out-patient clinics with ambulatory ECG monitoring in general practice. - [Erythrocyte sodium-lithium countertransport in African American women](https://niche.org.uk/publications/erythrocyte-sodium-lithium-countertransport-in-african-american-women/) - Erythrocyte sodium-lithium countertransport in African American women - [Pharmacokinetics and tolerability of GW420867X, a nonnucleoside reverse transcriptase inhibitor, following single escalating doses in healthy male volunteers](https://niche.org.uk/publications/pharmacokinetics-and-tolerability-of-gw420867x-a-nonnucleoside-reverse-transcriptase-inhibitor-following-single-escalating-doses-in-healthy-male-volunteers/) - Pharmacokinetics and tolerability of GW420867X, a nonnucleoside reverse transcriptase inhibitor, following single escalating doses in healthy male volunteers - [Effects of timing of administration and meal composition on the pharmacokinetic and pharmacodynamic characteristics of the short-acting oral hypoglycemic agent nateglinide in healthy subjects](https://niche.org.uk/publications/effects-of-timing-of-administration-and-meal-composition-on-the-pharmacokinetic-and-pharmacodynamic-characteristics-of-the-short-acting-oral-hypoglycemic-agent-nateglinide-in-healthy-subjects/) - Effects of timing of administration and meal composition on the pharmacokinetic and pharmacodynamic characteristics of the short-acting oral hypoglycemic agent nateglinide in healthy subjects - [Study protocol for the evaluation of the potential for durable viral suppression after quadruple HAART with or without HIV vaccination: the QUEST study](https://niche.org.uk/publications/study-protocol-for-the-evaluation-of-the-potential-for-durable-viral-suppression-after-quadruple-haart-with-or-without-hiv-vaccination-the-quest-study/) - Study protocol for the evaluation of the potential for durable viral suppression after quadruple HAART with or without HIV vaccination: the QUEST study - [Apolipoprotein E gene polymorphism and sodium-lithium countertransport activity](https://niche.org.uk/publications/apolipoprotein-e-gene-polymorphism-and-sodium-lithium-countertransport-activity/) - Apolipoprotein E gene polymorphism and sodium-lithium countertransport activity - [Influence of plasma phytanic acid levels in Refsum's disease on the behaviour of the erythrocyte membrane sodium-lithium countertransporter.](https://niche.org.uk/publications/influence-of-plasma-phytanic-acid-levels-in-refsum’s-disease-on-the-behaviour-of-the-erythrocyte-membrane-sodium-lithium-countertransporter/) - Influence of plasma phytanic acid levels in Refsum’s disease on the behaviour of the erythrocyte membrane sodium-lithium countertransporter. - [Sodium-lithium countertransport activity is linked to chromosome 5 in baboons](https://niche.org.uk/publications/sodium-lithium-countertransport-activity-is-linked-to-chromosome-5-in-baboons/) - Sodium-lithium countertransport activity is linked to chromosome 5 in baboons - [Parallel decline of CD8+/CD38++ T cells and viraemia in response to quadruple highly active antiretroviral therapy in primary HIV infection](https://niche.org.uk/publications/parallel-decline-of-cd8-cd38-t-cells-and-viraemia-in-response-to-quadruple-highly-active-antiretroviral-therapy-in-primary-hiv-infection/) - Parallel decline of CD8+/CD38++ T cells and viraemia in response to quadruple highly active antiretroviral therapy in primary HIV infection - [Low levels of perforin expression in CD8+ T lymphocyte granules in lymphoid tissue during acute human immunodeficiency virus type 1 infection](https://niche.org.uk/publications/low-levels-of-perforin-expression-in-cd8-t-lymphocyte-granules-in-lymphoid-tissue-during-acute-human-immunodeficiency-virus-type-1-infection/) - Low levels of perforin expression in CD8+ T lymphocyte granules in lymphoid tissue during acute human immunodeficiency virus type 1 infection - [The apolipoprotein E2 allele modulates activity and maximal velocity of the sodium-lithium countertransporter](https://niche.org.uk/publications/the-apolipoprotein-e2-allele-modulates-activity-and-maximal-velocity-of-the-sodium-lithium-countertransporter/) - The apolipoprotein E2 allele modulates activity and maximal velocity of the sodium-lithium countertransporter - [Pharmacokinetics of GW433908, a prodrug of amprenavir, in healthy male volunteers](https://niche.org.uk/publications/pharmacokinetics-of-gw433908-a-prodrug-of-amprenavir-in-healthy-male-volunteers/) - Pharmacokinetics of GW433908, a prodrug of amprenavir, in healthy male volunteers - [Correction for the adverse influence of sodium-potassium cotransport on apparent sodium-lithium countertransport activity in human erythrocytes](https://niche.org.uk/publications/correction-for-the-adverse-influence-of-sodium-potassium-cotransport-on-apparent-sodium-lithium-countertransport-activity-in-human-erythrocytes/) - Correction for the adverse influence of sodium-potassium cotransport on apparent sodium-lithium countertransport activity in human erythrocytes - [The cardiological complications associated with HIV infection and acquired immune deficiency syndrome (AIDS).](https://niche.org.uk/publications/the-cardiological-complications-associated-with-hiv-infection-and-acquired-immune-deficiency-syndrome-aids/) - The cardiological complications associated with HIV infection and acquired immune deficiency syndrome (AIDS). - [No effect of the novel antidiabetic agent nateglinide on the pharmacokinetics and anticoagulant properties of warfarin in healthy volunteers](https://niche.org.uk/publications/no-effect-of-the-novel-antidiabetic-agent-nateglinide-on-the-pharmacokinetics-and-anticoagulant-properties-of-warfarin-in-healthy-volunteers/) - No effect of the novel antidiabetic agent nateglinide on the pharmacokinetics and anticoagulant properties of warfarin in healthy volunteers - [Pharmacokinetics and systemic effects of inhaled fluticasone propionate in chronic obstructive pulmonary disease](https://niche.org.uk/publications/pharmacokinetics-and-systemic-effects-of-inhaled-fluticasone-propionate-in-chronic-obstructive-pulmonary-disease/) - Pharmacokinetics and systemic effects of inhaled fluticasone propionate in chronic obstructive pulmonary disease - [The effect of nateglinide taken with food on gastric emptying rates in healthy subjects](https://niche.org.uk/publications/the-effect-of-nateglinide-taken-with-food-on-gastric-emptying-rates-in-healthy-subjects/) - The effect of nateglinide taken with food on gastric emptying rates in healthy subjects - [The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy-naive HIV-1-infected patients](https://niche.org.uk/publications/the-neat-study-a-48-week-open-label-study-to-compare-the-antiviral-efficacy-and-safety-of-gw433908-versus-nelfinavir-in-antiretroviral-therapy-naive-hiv-1-infected-patients/) - The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy-naive HIV-1-infected patients - [A placebo-controlled crossover study comparing the effects of nateglinide and glibenclamide on postprandial hyperglycaemia and hyperinsulinaemia in patients with type 2 diabetes](https://niche.org.uk/publications/a-placebo-controlled-crossover-study-comparing-the-effects-of-nateglinide-and-glibenclamide-on-postprandial-hyperglycaemia-and-hyperinsulinaemia-in-patients-with-type-2-diabetes/) - A placebo-controlled crossover study comparing the effects of nateglinide and glibenclamide on postprandial hyperglycaemia and hyperinsulinaemia in patients with type 2 diabetes - [Evaluation of the future supply and demand for blood products in the United Kingdom National Health Service](https://niche.org.uk/publications/evaluation-of-the-future-supply-and-demand-for-blood-products-in-the-united-kingdom-national-health-service/) - Evaluation of the future supply and demand for blood products in the United Kingdom National Health Service - [Evaluating the performance of the Framingham risk equations in a population with diabetes](https://niche.org.uk/publications/evaluating-the-performance-of-the-framingham-risk-equations-in-a-population-with-diabetes/) - Evaluating the performance of the Framingham risk equations in a population with diabetes - [GW433908/ritonavir once daily in antiretroviral therapy-naive HIV-infected patients: absence of protease resistance at 48 weeks](https://niche.org.uk/publications/gw433908-ritonavir-once-daily-in-antiretroviral-therapy-naive-hiv-infected-patients-absence-of-protease-resistance-at-48-weeks/) - GW433908/ritonavir once daily in antiretroviral therapy-naive HIV-infected patients: absence of protease resistance at 48 weeks - [Brief but efficient: acute HIV infection and the sexual transmission of HIV](https://niche.org.uk/publications/brief-but-efficient-acute-hiv-infection-and-the-sexual-transmission-of-hiv/) - Brief but efficient: acute HIV infection and the sexual transmission of HIV - [Should we routinely measure a proxy for insulin resistance as well as improve our modelling techniques to better predict the likelihood of coronary heart disease in people with type 2 diabetes? For debate](https://niche.org.uk/publications/should-we-routinely-measure-a-proxy-for-insulin-resistance-as-well-as-improve-our-modelling-techniques-to-better-predict-the-likelihood-of-coronary-heart-disease-in-people-with-type-2-diabetes-for-de/) - Should we routinely measure a proxy for insulin resistance as well as improve our modelling techniques to better predict the likelihood of coronary heart disease in people with type 2 diabetes? For debate - [Safety of AT-1015, a novel 5-HT2A antagonist, in combination with high-dose aspirin: an open-label study](https://niche.org.uk/publications/safety-of-at-1015-a-novel-5-ht2a-antagonist-in-combination-with-high-dose-aspirin-an-open-label-study/) - Safety of AT-1015, a novel 5-HT2A antagonist, in combination with high-dose aspirin: an open-label study - [SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir /ritonavir versus twice-daily nelfinavir in naive HIV-1-infected patients](https://niche.org.uk/publications/solo-48-week-efficacy-and-safety-comparison-of-once-daily-fosamprenavir-ritonavir-versus-twice-daily-nelfinavir-in-naive-hiv-1-infected-patients/) - SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir /ritonavir versus twice-daily nelfinavir in naive HIV-1-infected patients - [Comparative estimates of the financial burden to the UK health system of hospital care for people with and without diabetes in the year before death](https://niche.org.uk/publications/comparative-estimates-of-the-financial-burden-to-the-uk-health-system-of-hospital-care-for-people-with-and-without-diabetes-in-the-year-before-death/) - Comparative estimates of the financial burden to the UK health system of hospital care for people with and without diabetes in the year before death - [A 42-week open-label study to assess the pharmacokinetics, antiretroviral activity, and safety of amprenavir or amprenavir plus ritonavir in combination with abacavir and lamivudine for treatment of HIV-infected patients](https://niche.org.uk/publications/a-42-week-open-label-study-to-assess-the-pharmacokinetics-antiretroviral-activity-and-safety-of-amprenavir-or-amprenavir-plus-ritonavir-in-combination-with-abacavir-and-lamivudine-for-treatment-of-h/) - A 42-week open-label study to assess the pharmacokinetics, antiretroviral activity, and safety of amprenavir or amprenavir plus ritonavir in combination with abacavir and lamivudine for treatment of HIV-infected patients - [The financial costs of hospital care for people with diabetes who have single and multiple macrovascular complications](https://niche.org.uk/publications/the-financial-costs-of-hospital-care-for-people-with-diabetes-who-have-single-and-multiple-macrovascular-complications/) - The financial costs of hospital care for people with diabetes who have single and multiple macrovascular complications - [Comparison of the systemic pharmacodynamic effects and pharmacokinetics of salmeterol delivered by CFC propellant and non-CFC propellant metered dose inhalers in healthy subjects](https://niche.org.uk/publications/comparison-of-the-systemic-pharmacodynamic-effects-and-pharmacokinetics-of-salmeterol-delivered-by-cfc-propellant-and-non-cfc-propellant-metered-dose-inhalers-in-healthy-subjects/) - Comparison of the systemic pharmacodynamic effects and pharmacokinetics of salmeterol delivered by CFC propellant and non-CFC propellant metered dose inhalers in healthy subjects - [Characterization of the metabolites of alosetron in experimental animals and human](https://niche.org.uk/publications/characterization-of-the-metabolites-of-alosetron-in-experimental-animals-and-human/) - Characterization of the metabolites of alosetron in experimental animals and human - [Impact of therapeutic immunization on HIV-1 viremia after discontinuation of antiretroviral therapy initiated during acute infection](https://niche.org.uk/publications/impact-of-therapeutic-immunization-on-hiv-1-viremia-after-discontinuation-of-antiretroviral-therapy-initiated-during-acute-infection/) - Impact of therapeutic immunization on HIV-1 viremia after discontinuation of antiretroviral therapy initiated during acute infection - [A double-blind study in healthy volunteers to assess the effects on sleep of pregabalin compared with alprazolam and placebo](https://niche.org.uk/publications/a-double-blind-study-in-healthy-volunteers-to-assess-the-effects-on-sleep-of-pregabalin-compared-with-alprazolam-and-placebo/) - A double-blind study in healthy volunteers to assess the effects on sleep of pregabalin compared with alprazolam and placebo - [A double-blind, placebo- and positive-internal-controlled (alprazolam) investigation of the cognitive and psychomotor profile of pregabalin in healthy volunteers](https://niche.org.uk/publications/a-double-blind-placebo-and-positive-internal-controlled-alprazolam-investigation-of-the-cognitive-and-psychomotor-profile-of-pregabalin-in-healthy-volunteers/) - A double-blind, placebo- and positive-internal-controlled (alprazolam) investigation of the cognitive and psychomotor profile of pregabalin in healthy volunteers - [Pulse pressure predicts cardiovascular risk in patients with type 2 diabetes mellitus](https://niche.org.uk/publications/pulse-pressure-predicts-cardiovascular-risk-in-patients-with-type-2-diabetes-mellitus/) - Pulse pressure predicts cardiovascular risk in patients with type 2 diabetes mellitus - [Characterization of SB-705498, a potent and selective vanilloid receptor-1 (VR1/TRPV1) antagonist that inhibits the capsaicin-, acid-, and heat-mediated activation of the receptor](https://niche.org.uk/publications/characterization-of-sb-705498-a-potent-and-selective-vanilloid-receptor-1-vr1-trpv1-antagonist-that-inhibits-the-capsaicin-acid-and-heat-mediated-activation-of-the-receptor/) - Characterization of SB-705498, a potent and selective vanilloid receptor-1 (VR1/TRPV1) antagonist that inhibits the capsaicin-, acid-, and heat-mediated activation of the receptor - [Predictors of virological outcome and safety in primary HIV type 1-infected patients initiating quadruple antiretroviral therapy: QUEST GW PROB3005](https://niche.org.uk/publications/predictors-of-virological-outcome-and-safety-in-primary-hiv-type-1-infected-patients-initiating-quadruple-antiretroviral-therapy-quest-gw-prob3005/) - Predictors of virological outcome and safety in primary HIV type 1-infected patients initiating quadruple antiretroviral therapy: QUEST GW PROB3005 - [A study to evaluate safety and efficacy of mepolizumab in patients with moderate persistent asthma](https://niche.org.uk/publications/a-study-to-evaluate-safety-and-efficacy-of-mepolizumab-in-patients-with-moderate-persistent-asthma/) - A study to evaluate safety and efficacy of mepolizumab in patients with moderate persistent asthma - [Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C](https://niche.org.uk/publications/eltrombopag-for-thrombocytopenia-in-patients-with-cirrhosis-associated-with-hepatitis-c/) - Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C - [(R)-8-(3-amino-piperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione (BI 1356), a novel xanthine-based dipeptidyl peptidase 4 inhibitor, has a superior potency and longer duration of action compared with other dipeptidyl peptidase-4 inhibitors](https://niche.org.uk/publications/r-8-3-amino-piperidin-1-yl-7-but-2-ynyl-3-methyl-1-4-methyl-quinazolin-2-ylmethyl-37-dihydro-purine-26-dione-bi-1356-a-novel-xanthine-based-dipeptidyl-peptidase-4-inhibitor-has-a-superior/) - (R)-8-(3-amino-piperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione (BI 1356), a novel xanthine-based dipeptidyl peptidase 4 inhibitor, has a superior potency and longer duration of action compared with other dipeptidyl peptidase-4 inhibitors - [HLA-B*5701 screening for hypersensitivity to abacavir](https://niche.org.uk/publications/hla-b5701-screening-for-hypersensitivity-to-abacavir/) - HLA-B*5701 screening for hypersensitivity to abacavir - [Ambulatory ECG monitoring in primary care.](https://niche.org.uk/publications/ambulatory-ecg-monitoring-in-primary-care/) - Ambulatory ECG monitoring in primary care. - [Lamotrigine does not prolong QTc in a thorough QT/QTc study in healthy subjects](https://niche.org.uk/publications/lamotrigine-does-not-prolong-qtc-in-a-thorough-qt-qtc-study-in-healthy-subjects/) - Lamotrigine does not prolong QTc in a thorough QT/QTc study in healthy subjects - [Safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of BI 1356, an inhibitor of dipeptidyl peptidase 4, in healthy male volunteers](https://niche.org.uk/publications/safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-single-oral-doses-of-bi-1356-an-inhibitor-of-dipeptidyl-peptidase-4-in-healthy-male-volunteers/) - Safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of BI 1356, an inhibitor of dipeptidyl peptidase 4, in healthy male volunteers - [Chronic Treatment with the Dipeptidyl Peptidase-4 Inhibitor BI 1356 [(R)-8-(3-Amino-piperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione] Increases Basal Glucagon-Like Peptide-1 and Improves Glycemic Control in Diabetic Rodent Models.](https://niche.org.uk/publications/chronic-treatment-with-the-dipeptidyl-peptidase-4-inhibitor-bi-1356-r-8-3-amino-piperidin-1-yl-7-but-2-ynyl-3-methyl-1-4-methyl-quinazolin-2-ylmethyl-37-dihydro-purine-26-dione-increases-bas/) - Chronic Treatment with the Dipeptidyl Peptidase-4 Inhibitor BI 1356 [(R)-8-(3-Amino-piperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione] Increases Basal Glucagon-Like Peptide-1 and Improves Glycemic Control in Diabetic Rodent Models. - [Concentration-dependent plasma protein binding of the novel dipeptidyl peptidase 4 inhibitor BI 1356 due to saturable binding to its target in plasma of mice, rats and humans](https://niche.org.uk/publications/concentration-dependent-plasma-protein-binding-of-the-novel-dipeptidyl-peptidase-4-inhibitor-bi-1356-due-to-saturable-binding-to-its-target-in-plasma-of-mice-rats-and-humans/) - Concentration-dependent plasma protein binding of the novel dipeptidyl peptidase 4 inhibitor BI 1356 due to saturable binding to its target in plasma of mice, rats and humans - [Long-term efficacy and safety of fosamprenavir plus ritonavir versus lopinavir/ritonavir in combination with abacavir/lamivudine over 144 weeks](https://niche.org.uk/publications/long-term-efficacy-and-safety-of-fosamprenavir-plus-ritonavir-versus-lopinavir-ritonavir-in-combination-with-abacavir-lamivudine-over-144-weeks/) - Long-term efficacy and safety of fosamprenavir plus ritonavir versus lopinavir/ritonavir in combination with abacavir/lamivudine over 144 weeks - [Future challenges for microsomal transport protein inhibitors](https://niche.org.uk/publications/future-challenges-for-microsomal-transport-protein-inhibitors/) - Future challenges for microsomal transport protein inhibitors - [Eltrombopag, an oral thrombopoietin receptor agonist, has no impact on the pharmacokinetic profile of probe drugs for cytochrome P450 isoenzymes CYP3A4, CYP1A2, CYP2C9 and CYP2C19 in healthy men: a cocktail analysis](https://niche.org.uk/publications/eltrombopag-an-oral-thrombopoietin-receptor-agonist-has-no-impact-on-the-pharmacokinetic-profile-of-probe-drugs-for-cytochrome-p450-isoenzymes-cyp3a4-cyp1a2-cyp2c9-and-cyp2c19-in-healthy-men-a-co/) - Eltrombopag, an oral thrombopoietin receptor agonist, has no impact on the pharmacokinetic profile of probe drugs for cytochrome P450 isoenzymes CYP3A4, CYP1A2, CYP2C9 and CYP2C19 in healthy men: a cocktail analysis - [Effect of Silicate-Substitution on Attachment and Early Development of Human Osteoblast-Like Cells Seeded on Microporous Hydroxyapatite Discs.](https://niche.org.uk/publications/effect-of-silicate-substitution-on-attachment-and-early-development-of-human-osteoblast-like-cells-seeded-on-microporous-hydroxyapatite-discs/) - Effect of Silicate-Substitution on Attachment and Early Development of Human Osteoblast-Like Cells Seeded on Microporous Hydroxyapatite Discs. - [The challenge of developing novel pharmacological therapies for non-alcoholic steatohepatitis](https://niche.org.uk/publications/the-challenge-of-developing-novel-pharmacological-therapies-for-non-alcoholic-steatohepatitis/) - The challenge of developing novel pharmacological therapies for non-alcoholic steatohepatitis - [An open-label, randomised study of dihydroartemisinin-piperaquine versus artesunate-mefloquine for falciparum malaria in Asia](https://niche.org.uk/publications/an-open-label-randomised-study-of-dihydroartemisinin-piperaquine-versus-artesunate-mefloquine-for-falciparum-malaria-in-asia/) - An open-label, randomised study of dihydroartemisinin-piperaquine versus artesunate-mefloquine for falciparum malaria in Asia - [Sodium-glucose co-transporter 2 inhibitors: from apple tree to 'Sweet Pee'](https://niche.org.uk/publications/sodium-glucose-co-transporter-2-inhibitors-from-apple-tree-to-sweet-pee/) - Sodium-glucose co-transporter 2 inhibitors: from apple tree to 'Sweet Pee' - [Increasing strut porosity in silicate-substituted calcium-phosphate bone graft substitutes enhances osteogenesis](https://niche.org.uk/publications/increasing-strut-porosity-in-silicate-substituted-calcium-phosphate-bone-graft-substitutes-enhances-osteogenesis/) - Increasing strut porosity in silicate-substituted calcium-phosphate bone graft substitutes enhances osteogenesis - [Establishing bioequivalence for inhaled drugs; weighing the evidence](https://niche.org.uk/publications/establishing-bioequivalence-for-inhaled-drugs-weighing-the-evidence/) - Establishing bioequivalence for inhaled drugs; weighing the evidence - [Choosing the right Omega-3 supplement: Natural Triglyceride Omega-3 versus Synthetic Ethyl Ester](https://niche.org.uk/publications/choosing-the-right-omega-3-supplement-natural-triglyceride-omega-3-versus-synthetic-ethyl-ester/) - Choosing the right Omega-3 supplement: Natural Triglyceride Omega-3 versus Synthetic Ethyl Ester - [Early and Visible Improvements after Application of K101 in the Appearance of Nails Discoloured and Deformed by Onychomycosis.](https://niche.org.uk/publications/early-and-visible-improvements-after-application-of-k101-in-the-appearance-of-nails-discoloured-and-deformed-by-onychomycosis/) - Early and Visible Improvements after Application of K101 in the Appearance of Nails Discoloured and Deformed by Onychomycosis. - [Efficacy, adherence and tolerability of once daily tenofovir DF-containing antiretroviral therapy in former injecting drug users with HIV-1 receiving opiate treatment: results of a 48-week open-label study](https://niche.org.uk/publications/efficacy-adherence-and-tolerability-of-once-daily-tenofovir-df-containing-antiretroviral-therapy-in-former-injecting-drug-users-with-hiv-1-receiving-opiate-treatment-results-of-a-48-week-open-label/) - Efficacy, adherence and tolerability of once daily tenofovir DF-containing antiretroviral therapy in former injecting drug users with HIV-1 receiving opiate treatment: results of a 48-week open-label study - [Development and potential role of type-2 sodium-glucose transporter inhibitors for management of type 2 diabetes](https://niche.org.uk/publications/development-and-potential-role-of-type-2-sodium-glucose-transporter-inhibitors-for-management-of-type-2-diabetes/) - Development and potential role of type-2 sodium-glucose transporter inhibitors for management of type 2 diabetes - [Kerasal Nail Clinical Studies Demonstrate Early Visible Improvements in Nails Damaged by Onychomycosis](https://niche.org.uk/publications/kerasal-nail-clinical-studies-demonstrate-early-visible-improvements-in-nails-damaged-by-onychomycosis/) - Kerasal Nail Clinical Studies Demonstrate Early Visible Improvements in Nails Damaged by Onychomycosis - [New lipid-lowering drugs: an update](https://niche.org.uk/publications/new-lipid-lowering-drugs-an-update/) - New lipid-lowering drugs: an update - [Inhibition of pro-protein convertase subtilisin kexin 9 [corrected] (PCSK-9) as a treatment for hyperlipidaemia](https://niche.org.uk/publications/inhibition-of-pro-protein-convertase-subtilisin-kexin-9-corrected-pcsk-9-as-a-treatment-for-hyperlipidaemia/) - Inhibition of pro-protein convertase subtilisin kexin 9 [corrected] (PCSK-9) as a treatment for hyperlipidaemia - [Treatment of distal subungual onychomycosis with a topical preparation of urea, propylene glycol and lactic acid: results of a 24-week, double-blind, placebo-controlled study](https://niche.org.uk/publications/treatment-of-distal-subungual-onychomycosis-with-a-topical-preparation-of-urea-propylene-glycol-and-lactic-acid-results-of-a-24-week-double-blind-placebo-controlled-study/) - Treatment of distal subungual onychomycosis with a topical preparation of urea, propylene glycol and lactic acid: results of a 24-week, double-blind, placebo-controlled study - [Directed osteogenic differentiation of human mesenchymal stem/precursor cells on silicate substituted calcium phosphate](https://niche.org.uk/publications/directed-osteogenic-differentiation-of-human-mesenchymal-stem-precursor-cells-on-silicate-substituted-calcium-phosphate/) - Directed osteogenic differentiation of human mesenchymal stem/precursor cells on silicate substituted calcium phosphate - [Renal and cardiac effects of DPP4 inhibitors--from preclinical development to clinical research](https://niche.org.uk/publications/renal-and-cardiac-effects-of-dpp4-inhibitors-from-preclinical-development-to-clinical-research/) - Renal and cardiac effects of DPP4 inhibitors--from preclinical development to clinical research - [Cardiovascular medication in women and urinary continence.](https://niche.org.uk/publications/cardiovascular-medication-in-women-and-urinary-continence/) - Cardiovascular medication in women and urinary continence. - [Pharmacokinetics, pharmacodynamics, and tolerability of GS-9851, a nucleotide analog polymerase inhibitor, following multiple ascending doses in patients with chronic hepatitis C infection](https://niche.org.uk/publications/pharmacokinetics-pharmacodynamics-and-tolerability-of-gs-9851-a-nucleotide-analog-polymerase-inhibitor-following-multiple-ascending-doses-in-patients-with-chronic-hepatitis-c-infection/) - Pharmacokinetics, pharmacodynamics, and tolerability of GS-9851, a nucleotide analog polymerase inhibitor, following multiple ascending doses in patients with chronic hepatitis C infection - [Pharmacokinetics, safety, and tolerability of GS-9851, a nucleotide analog polymerase inhibitor for hepatitis C virus, following single ascending doses in healthy subjects](https://niche.org.uk/publications/pharmacokinetics-safety-and-tolerability-of-gs-9851-a-nucleotide-analog-polymerase-inhibitor-for-hepatitis-c-virus-following-single-ascending-doses-in-healthy-subjects/) - Pharmacokinetics, safety, and tolerability of GS-9851, a nucleotide analog polymerase inhibitor for hepatitis C virus, following single ascending doses in healthy subjects - [Phase II clinical study of BC-3781, a pleuromutilin antibiotic, in treatment of patients with acute bacterial skin and skin structure infections](https://niche.org.uk/publications/phase-ii-clinical-study-of-bc-3781-a-pleuromutilin-antibiotic-in-treatment-of-patients-with-acute-bacterial-skin-and-skin-structure-infections/) - Phase II clinical study of BC-3781, a pleuromutilin antibiotic, in treatment of patients with acute bacterial skin and skin structure infections - [New therapies in the management of type 2 diabetes mellitus](https://niche.org.uk/publications/new-therapies-in-the-management-of-type-2-diabetes-mellitus/) - New therapies in the management of type 2 diabetes mellitus - [Eight weeks of supplementation with a multi-ingredient weight loss product enhances body composition, reduces hip and waist girth, and increases energy levels in overweight men and women](https://niche.org.uk/publications/eight-weeks-of-supplementation-with-a-multi-ingredient-weight-loss-product-enhances-body-composition-reduces-hip-and-waist-girth-and-increases-energy-levels-in-overweight-men-and-women/) - Eight weeks of supplementation with a multi-ingredient weight loss product enhances body composition, reduces hip and waist girth, and increases energy levels in overweight men and women - [Efficacy, safety and tolerability of GSK2190915, a 5-lipoxygenase activating protein inhibitor, in adults and adolescents with persistent asthma: a randomised dose-ranging study](https://niche.org.uk/publications/efficacy-safety-and-tolerability-of-gsk2190915-a-5-lipoxygenase-activating-protein-inhibitor-in-adults-and-adolescents-with-persistent-asthma-a-randomised-dose-ranging-study/) - Efficacy, safety and tolerability of GSK2190915, a 5-lipoxygenase activating protein inhibitor, in adults and adolescents with persistent asthma: a randomised dose-ranging study - [New therapies to reduce low-density lipoprotein cholesterol](https://niche.org.uk/publications/new-therapies-to-reduce-low-density-lipoprotein-cholesterol/) - New therapies to reduce low-density lipoprotein cholesterol - [Effect of ONO-5334 on bone mineral density and biochemical markers of bone turnover in postmenopausal osteoporosis: 2-year results from the OCEAN study](https://niche.org.uk/publications/effect-of-ono-5334-on-bone-mineral-density-and-biochemical-markers-of-bone-turnover-in-postmenopausal-osteoporosis-2-year-results-from-the-ocean-study/) - Effect of ONO-5334 on bone mineral density and biochemical markers of bone turnover in postmenopausal osteoporosis: 2-year results from the OCEAN study - [The efficacy and safety of ropinirole prolonged release tablets as adjunctive therapy in Chinese subjects with advanced Parkinson's disease: a multicenter, double-blind, randomized, placebo-controlled study](https://niche.org.uk/publications/the-efficacy-and-safety-of-ropinirole-prolonged-release-tablets-as-adjunctive-therapy-in-chinese-subjects-with-advanced-parkinsons-disease-a-multicenter-double-blind-randomized-placebo-controlled/) - The efficacy and safety of ropinirole prolonged release tablets as adjunctive therapy in Chinese subjects with advanced Parkinson's disease: a multicenter, double-blind, randomized, placebo-controlled study - [An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes--the MID-Frail study: study protocol for a randomised controlled trial](https://niche.org.uk/publications/an-evaluation-of-the-effectiveness-of-a-multi-modal-intervention-in-frail-and-pre-frail-older-people-with-type-2-diabetes-the-mid-frail-study-study-protocol-for-a-randomised-controlled-trial/) - An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes--the MID-Frail study: study protocol for a randomised controlled trial - [Sarcoidosis: the links between epidemiology and aetiology](https://niche.org.uk/publications/sarcoidosis-the-links-between-epidemiology-and-aetiology/) - Sarcoidosis: the links between epidemiology and aetiology - [Prostacyclin Synthase: Upregulation during Renal Development and in Glomerular Disease as well as Its Constitutive Expression in Cultured Human Mesangial Cells](https://niche.org.uk/publications/prostacyclin-synthase-upregulation-during-renal-development-and-in-glomerular-disease-as-well-as-its-constitutive-expression-in-cultured-human-mesangial-cells/) - Prostacyclin Synthase: Upregulation during Renal Development and in Glomerular Disease as well as Its Constitutive Expression in Cultured Human Mesangial Cells - [Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open-label, non-randomised, phase 3 study](https://niche.org.uk/publications/sofosbuvir-plus-ribavirin-for-treatment-of-hepatitis-c-virus-in-patients-co-infected-with-hiv-photon-2-a-multicentre-open-label-non-randomised-phase-3-study/) - Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open-label, non-randomised, phase 3 study - [Impact and management of chemotherapy/radiotherapy-induced nausea and vomiting and the perceptual gap between oncologists/oncology nurses and patients: a cross-sectional multinational survey](https://niche.org.uk/publications/impact-and-management-of-chemotherapy-radiotherapy-induced-nausea-and-vomiting-and-the-perceptual-gap-between-oncologists-oncology-nurses-and-patients-a-cross-sectional-multinational-survey/) - Impact and management of chemotherapy/radiotherapy-induced nausea and vomiting and the perceptual gap between oncologists/oncology nurses and patients: a cross-sectional multinational survey - [A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus](https://niche.org.uk/publications/a-phase-1-randomized-dose-ranging-study-of-gs-5816-a-once-daily-ns5a-inhibitor-in-patients-with-genotype-1-4-hepatitis-c-virus/) - A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus - [In Search of 'Omics'-Based Biomarkers to Predict Risk of Frailty and Its Consequences in Older Individuals: The FRAILOMIC Initiative](https://niche.org.uk/publications/in-search-of-‘omics’-based-biomarkers-topredict-risk-of-frailty-and-its-consequences-inolder-individuals-the-frailomic-initiative/) - In Search of ‘Omics’-Based Biomarkers to Predict Risk of Frailty and Its Consequences in Older Individuals: The FRAILOMIC Initiative - [Research in progress: Medical Research Council United Kingdom Refractory Asthma Stratification Programme (RASP-UK)](https://niche.org.uk/publications/research-in-progress-medical-research-council-united-kingdom-refractory-asthma-stratification-programme-rasp-uk/) - Research in progress: Medical Research Council United Kingdom Refractory Asthma Stratification Programme (RASP-UK) - [Safety, Tolerability, and Pharmacokinetic Profile of the Novel Translocator Protein 18 kDa Antagonist ONO-2952 in Healthy Volunteers](https://niche.org.uk/publications/safety-tolerability-and-pharmacokinetic-profile-of-the-novel-translocator-protein-18-kda-antagonist-ono-2952-in-healthy-volunteers/) - Safety, Tolerability, and Pharmacokinetic Profile of the Novel Translocator Protein 18 kDa Antagonist ONO-2952 in Healthy Volunteers - [Assessment of SiCaP-30 in a Rabbit Posterolateral Fusion Model with Concurrent Chemotherapy](https://niche.org.uk/publications/assessment-of-sicap-30-in-a-rabbit-posterolateral-fusion-model-with-concurrent-chemotherapy/) - Assessment of SiCaP-30 in a Rabbit Posterolateral Fusion Model with Concurrent Chemotherapy - [Morning vs evening dosing of the cathepsin K inhibitor ONO-5334: effects on bone resorption in postmenopausal women in a randomized, phase 1 trial](https://niche.org.uk/publications/morning-vs-evening-dosing-of-the-cathepsin-k-inhibitor-ono-5334-effects-on-bone-resorption-in-postmenopausal-women-in-a-randomized-phase-1-trial/) - Morning vs evening dosing of the cathepsin K inhibitor ONO-5334: effects on bone resorption in postmenopausal women in a randomized, phase 1 trial - [EP3/FP dual receptor agonist ONO-9054 administered morning or evening to patients with open-angle glaucoma or ocular hypertension: results of a randomised crossover study](https://niche.org.uk/publications/ep3-fp-dual-receptor-agonist-ono-9054-administered-morning-or-evening-to-patients-with-open-angle-glaucoma-or-ocular-hypertension-results-of-a-randomised-crossover-study/) - EP3/FP dual receptor agonist ONO-9054 administered morning or evening to patients with open-angle glaucoma or ocular hypertension: results of a randomised crossover study - [Sofosbuvir Plus Velpatasvir Combination Therapy for Treatment-Experienced Patients With Genotype 1 or 3 Hepatitis C Virus Infection: A Randomized Trial](https://niche.org.uk/publications/sofosbuvir-plus-velpatasvir-combination-therapy-for-treatment-experienced-patients-with-genotype-1-or-3-hepatitis-c-virus-infection-a-randomized-trial/) - Sofosbuvir Plus Velpatasvir Combination Therapy for Treatment-Experienced Patients With Genotype 1 or 3 Hepatitis C Virus Infection: A Randomized Trial - [Sofosbuvir With Velpatasvir in Treatment-Naive Noncirrhotic Patients With Genotype 1 to 6 Hepatitis C Virus Infection: A Randomized Trial](https://niche.org.uk/publications/sofosbuvir-with-velpatasvir-in-treatment-naive-noncirrhotic-patients-with-genotype-1-to-6-hepatitis-c-virus-infection-a-randomized-trial/) - Sofosbuvir With Velpatasvir in Treatment-Naive Noncirrhotic Patients With Genotype 1 to 6 Hepatitis C Virus Infection: A Randomized Trial - [Simultaneous assessment of the pharmacokinetics of a pleuromutilin, lefamulin, in plasma, soft tissues and pulmonary epithelial lining fluid](https://niche.org.uk/publications/simultaneous-assessment-of-the-pharmacokinetics-of-a-pleuromutilin-lefamulin-in-plasma-soft-tissues-and-pulmonary-epithelial-lining-fluid/) - Simultaneous assessment of the pharmacokinetics of a pleuromutilin, lefamulin, in plasma, soft tissues and pulmonary epithelial lining fluid - [Pharmacokinetics, Safety, and Tolerability Following the Administration of a Single Dose of a Combination Tablet Containing Sumatriptan and Naproxen Sodium in Adolescent Patients With Migraine and in Healthy Adult Volunteers](https://niche.org.uk/publications/pharmacokinetics-safety-and-tolerability-following-the-administration-of-a-single-dose-of-a-combination-tablet-containing-sumatriptan-and-naproxen-sodium-in-adolescent-patients-with-migraine-and-in/) - Pharmacokinetics, Safety, and Tolerability Following the Administration of a Single Dose of a Combination Tablet Containing Sumatriptan and Naproxen Sodium in Adolescent Patients With Migraine and in Healthy Adult Volunteers - [A single and multiple dose study to investigate the pharmacokinetics of a prolonged release formulation of ropinirole in healthy Chinese subjects](https://niche.org.uk/publications/a-single-and-multiple-dose-study-to-investigate-the-pharmacokinetics-of-a-prolonged-release-formulation-of-ropinirole-in-healthy-chinese-subjects/) - A single and multiple dose study to investigate the pharmacokinetics of a prolonged release formulation of ropinirole in healthy Chinese subjects - [Constipation in older people: A consensus statement](https://niche.org.uk/publications/constipation-in-older-people-a-consensus-statement/) - Constipation in older people: A consensus statement - [Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial](https://niche.org.uk/publications/targeted-release-budesonide-versus-placebo-in-patients-with-iga-nephropathy-nefigan-a-double-blind-randomised-placebo-controlled-phase-2b-trial/) - Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial - [Ready! Aim! Fire! targeting the right medical science journal](https://niche.org.uk/publications/ready-aim-fire-targeting-the-right-medical-science-journal/) - Ready! Aim! Fire! targeting the right medical science journal - [A randomised pragmatic trial of corticosteroid optimization in severe asthma using a composite biomarker algorithm to adjust corticosteroid dose versus standard care: study protocol for a randomised trial](https://niche.org.uk/publications/a-randomised-pragmatic-trial-of-corticosteroid-optimization-in-severe-asthma-using-a-composite-biomarker-algorithm-to-adjust-corticosteroid-dose-versus-standard-care-study-protocol-for-a-randomised-t/) - A randomised pragmatic trial of corticosteroid optimization in severe asthma using a composite biomarker algorithm to adjust corticosteroid dose versus standard care: study protocol for a randomised trial - [EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and Risk Management](https://niche.org.uk/publications/eufemed-london-conference-2017-exploratory-medicines-development-innovation-and-risk-management/) - EUFEMED London Conference 2017: Exploratory Medicines Development: Innovation and Risk Management - [A Prospective, Randomized, Multicenter Study Comparing Silicated Calcium Phosphate versus BMP-2 Synthetic Bone Graft in Posterolateral Instrumented Lumbar Fusion for Degenerative Spinal Disorders](https://niche.org.uk/publications/a-prospective-randomized-multicenter-study-comparing-silicated-calcium-phosphate-versus-bmp-2-synthetic-bone-graft-in-posterolateral-instrumented-lumbar-fusion-for-degenerative-spinal-disorders/) - A Prospective, Randomized, Multicenter Study Comparing Silicated Calcium Phosphate versus BMP-2 Synthetic Bone Graft in Posterolateral Instrumented Lumbar Fusion for Degenerative Spinal Disorders - [The Association for Human Pharmacology in the Pharmaceutical Industry London Meeting 2018: Brexit and Other Challenges in Early Phase Drug Development](https://niche.org.uk/publications/the-association-for-human-pharmacology-in-the-pharmaceutical-industry-london-meeting-2018-brexit-and-other-challenges-in-early-phase-drug-development/) - The Association for Human Pharmacology in the Pharmaceutical Industry London Meeting 2018: Brexit and Other Challenges in Early Phase Drug Development - [Effectiveness of a multimodal intervention in functionally impaired older people with type 2 diabetes mellitus](https://niche.org.uk/publications/effectiveness-of-a-multimodal-intervention-in-functionally-impaired-older-people-with-type-2-diabetes-mellitus/) - Effectiveness of a multimodal intervention in functionally impaired older people with type 2 diabetes mellitus - [The New First-in-Human EMA Guideline: Disruptive or Constructive? Outcomes From the First EUFEMED Discussion Forum](https://niche.org.uk/publications/the-new-first-in-human-ema-guideline-disruptive-or-constructive-outcomes-from-the-first-eufemed-discussion-forum/) - The New First-in-Human EMA Guideline: Disruptive or Constructive? Outcomes From the First EUFEMED Discussion Forum - [European Federation for Exploratory Medicines Development Lyon Conference 2019: The Changing Landscape of Early Medicines Development-Be Prepared](https://niche.org.uk/publications/european-federation-for-exploratory-medicines-development-lyon-conference-2019-the-changing-landscape-of-early-medicines-development-be-prepared/) - European Federation for Exploratory Medicines Development Lyon Conference 2019: The Changing Landscape of Early Medicines Development-Be Prepared - [Ten tips for promoting your research.](https://niche.org.uk/publications/ten-tips-for-promoting-your-research/) - Ten tips for promoting your research. - [Programmed death ligand 1 protein expression, histological tumour differentiation and intratumoural heterogeneity in pulmonary adenocarcinoma](https://niche.org.uk/publications/programmed-death-ligand-1-protein-expression-histological-tumour-differentiation-and-intratumoural-heterogeneity-in-pulmonary-adenocarcinoma/) - Programmed death ligand 1 protein expression, histological tumour differentiation and intratumoural heterogeneity in pulmonary adenocarcinoma - [Composite type-2 biomarker strategy versus a symptom-risk-based algorithm to adjust corticosteroid dose in patients with severe asthma: a multicentre, single-blind, parallel group, randomised controlled trial](https://niche.org.uk/publications/composite-type-2-biomarker-strategy-versus-a-symptom-risk-based-algorithm-to-adjust-corticosteroid-dose-in-patients-with-severe-asthma-a-multicentre-single-blind-parallel-group-randomised-controll/) - Composite type-2 biomarker strategy versus a symptom-risk-based algorithm to adjust corticosteroid dose in patients with severe asthma: a multicentre, single-blind, parallel group, randomised controlled trial - [The Association for Human Pharmacology in the Pharmaceutical Industry London Meeting October 2019: Impending Change, Innovation, and Future Challenges](https://niche.org.uk/publications/the-association-for-human-pharmacology-in-the-pharmaceutical-industry-london-meeting-october-2019-impending-change-innovation-and-future-challenges/) - The Association for Human Pharmacology in the Pharmaceutical Industry London Meeting October 2019: Impending Change, Innovation, and Future Challenges - [Disease Severity Impact on Long-Term Virologic Response to Ibalizumab In Expanded Access Protocol (Tmb-311)](https://niche.org.uk/publications/disease-severity-impact-on-long-term-virologic-response-to-ibalizumab-in-expanded-access-protocol-tmb-311/) - Disease Severity Impact on Long-Term Virologic Response to Ibalizumab In Expanded Access Protocol (Tmb-311) - [How to Interpret an Investigator's Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion Forum](https://niche.org.uk/publications/how-to-interpret-an-investigators-brochure-for-meaningful-risk-assessment-results-of-an-agah-discussion-forum/) - How to Interpret an Investigator's Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion Forum - [A robust machine learning framework to identify signatures for frailty: a nested case-control study in four aging European cohorts](https://niche.org.uk/publications/a-robust-machine-learning-framework-to-identify-signatures-for-frailty-a-nested-case-control-study-in-four-aging-european-cohorts/) - A robust machine learning framework to identify signatures for frailty: a nested case-control study in four aging European cohorts - [Challenges of working from home during the COVID-19 pandemic: A survey to inform working practices. Medical Writing](https://niche.org.uk/publications/challenges-of-working-from-home-during-the-covid-19-pandemic-a-survey-to-inform-working-practices-medical-writing/) - Challenges of working from home during the COVID-19 pandemic: A survey to inform working practices. Medical Writing - [Factors affecting adherence with treatment advice in a clinical trial of patients with severe asthma](https://niche.org.uk/publications/factors-affecting-adherence-with-treatment-advice-in-a-clinical-trial-of-patients-with-severe-asthma/) - Factors affecting adherence with treatment advice in a clinical trial of patients with severe asthma - [Open-label use of an aliphatic polyamine immunomodulator in patients hospitalized with COVID-19](https://niche.org.uk/publications/open-label-use-of-an-aliphatic-polyamine-immunomodulator-in-patients-hospitalized-with-covid-19/) - Open-label use of an aliphatic polyamine immunomodulator in patients hospitalized with COVID-19 - [Relationship between inflammatory status and microbial composition in severe asthma and during exacerbation](https://niche.org.uk/publications/relationship-between-inflammatory-status-and-microbial-composition-in-severe-asthma-and-during-exacerbation/) - Relationship between inflammatory status and microbial composition in severe asthma and during exacerbation - [Changes to working practices in medical communications during the COVID-19 pandemic: Insights from two surveys.](https://niche.org.uk/publications/changes-to-working-practices-in-medical-communications-during-the-covid-19-pandemic-insights-from-two-surveys/) - Changes to working practices in medical communications during the COVID-19 pandemic: Insights from two surveys. - [Analysis of the safety and immunogenicity profile of an azoximer bromide polymer-adjuvanted subunit influenza vaccine](https://niche.org.uk/publications/analysis-of-the-safety-and-immunogenicity-profile-of-an-azoximer-bromide-polymer-adjuvanted-subunit-influenza-vaccine/) - Analysis of the safety and immunogenicity profile of an azoximer bromide polymer-adjuvanted subunit influenza vaccine - [A Randomized Trial of a Composite T2-Biomarker Strategy Adjusting Corticosteroid Treatment in Severe Asthma: A Post Hoc Analysis by Sex](https://niche.org.uk/publications/a-randomized-trial-of-a-composite-t2-biomarker-strategy-adjusting-corticosteroid-treatment-in-severe-asthma-a-post-hoc-analysis-by-sex/) - A Randomized Trial of a Composite T2-Biomarker Strategy Adjusting Corticosteroid Treatment in Severe Asthma: A Post Hoc Analysis by Sex - [The future of clinical trials and drug development: 2050](https://niche.org.uk/publications/the-future-of-clinical-trials-and-drug-development-2050/) - The future of clinical trials and drug development: 2050 - [In bed with the enemy.](https://niche.org.uk/publications/in-bed-with-the-enemy/) - In bed with the enemy. - [Sodium-lithium countertransport in patients with Refsum's disease.](https://niche.org.uk/publications/sodium-lithium-countertransport-in-patients-with-refsum’s-disease/) - Sodium-lithium countertransport in patients with Refsum’s disease. - [Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challenges](https://niche.org.uk/publications/association-for-human-pharmacology-in-the-pharmaceutical-industry-conference-2022-impending-change-innovations-and-future-challenges/) - Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challenges - [Evaluation of NTP42, a novel thromboxane receptor antagonist, in a first-in-human phase I clinical trial](https://niche.org.uk/publications/evaluation-of-ntp42-a-novel-thromboxane-receptor-antagonist-in-a-first-in-human-phase-i-clinical-trial/) - Evaluation of NTP42, a novel thromboxane receptor antagonist, in a first-in-human phase I clinical trial - [Impact of the COVID-19 Pandemic on Clinical Trial Conduct: Lessons for the Future.](https://niche.org.uk/publications/impact-of-the-covid-19-pandemic-on-clinical-trial-conduct-lessons-for-the-future/) - Impact of the COVID-19 Pandemic on Clinical Trial Conduct: Lessons for the Future. - [Assessment of Genotypic Patterns Associated with HIV-1 Sensitivity to Ibalizumab](https://niche.org.uk/publications/assessment-of-genotypic-patterns-associated-with-hiv-1-sensitivity-to-ibalizumab/) - Assessment of Genotypic Patterns Associated with HIV-1 Sensitivity to Ibalizumab - [Corticosteroid optimisation in severe asthma using composite biomarkers to adjust dose versus a symptom/risk-based algorithm E-POSTER Nr 4618](https://niche.org.uk/publications/corticosteroid-optimisation-in-severe-asthma-using-composite-biomarkers-to-adjust-dose-versus-a-symptom-risk-based-algorithm-e-poster-nr-4618/) - Corticosteroid optimisation in severe asthma using composite biomarkers to adjust dose versus a symptom/risk-based algorithm E-POSTER Nr 4618 - [Natriuretic peptides and heart failure: diagnosis, prognosis and treatment.](https://niche.org.uk/publications/natriuretic-peptides-and-heart-failure-diagnosis-prognosis-and-treatment/) - Natriuretic peptides and heart failure: diagnosis, prognosis and treatment. - [Exercise electrocardiography and aortic Doppler velocimetry in asymptomatic identical twins discordant for type 1 (insulin dependent) diabetes.](https://niche.org.uk/publications/exercise-electrocardiography-and-aortic-doppler-velocimetry-in-asymptomatic-identical-twins-discordant-for-type-1-insulin-dependent-diabetes/) - Exercise electrocardiography and aortic Doppler velocimetry in asymptomatic identical twins discordant for type 1 (insulin dependent) diabetes. - [Erythrocyte sodium lithium countertransport (SLC) activity and retinol binding protein (RBP) in healthy normotensive subjects.](https://niche.org.uk/publications/erythrocyte-sodium-lithium-countertransport-slc-activity-and-retinol-binding-protein-rbp-in-healthy-normotensive-subjects/) - Erythrocyte sodium lithium countertransport (SLC) activity and retinol binding protein (RBP) in healthy normotensive subjects. - [Urine pterin levels in patients with pre-cancerous lesions of the uterine cervix.](https://niche.org.uk/publications/urine-pterin-levels-in-patients-with-pre-cancerous-lesions-of-the-uterine-cervix/) - Urine pterin levels in patients with pre-cancerous lesions of the uterine cervix. - [Influence of Renal and Hepatic Impairment on the Pharmacokinetic and Pharmacodynamic Properties and Tolerability of Fluticasone Furoate and Vilanterol in Combination](https://niche.org.uk/publications/influence-of-renal-and-hepatic-impairment-on-the-pharmacokinetic-and-pharmacodynamic-properties-and-tolerability-of-fluticasone-furoate-and-vilanterol-in-combination/) - Influence of Renal and Hepatic Impairment on the Pharmacokinetic and Pharmacodynamic Properties and Tolerability of Fluticasone Furoate and Vilanterol in Combination - [Comparison of traditional and bicarbonate lithium loading methods on the characteristics of the sodium-lithium countertransporter (SLC).](https://niche.org.uk/publications/comparison-of-traditional-and-bicarbonate-lithium-loading-methods-on-the-characteristics-of-the-sodium-lithium-countertransporter-slc/) - Comparison of traditional and bicarbonate lithium loading methods on the characteristics of the sodium-lithium countertransporter (SLC). - [Effects of exposure to lead and cadmium on metabolism of vitamin D3 in smelter workers.](https://niche.org.uk/publications/effects-of-exposure-to-lead-and-cadmium-on-metabolism-of-vitamin-d3-in-smelter-workers/) - Effects of exposure to lead and cadmium on metabolism of vitamin D3 in smelter workers. - [Reductions in blood lead in school children since the phase-down of the use of lead in petrol.](https://niche.org.uk/publications/reductions-in-blood-lead-in-school-children-since-the-phase-down-of-the-use-of-lead-in-petrol/) - Reductions in blood lead in school children since the phase-down of the use of lead in petrol. - [Iron deficiency in a cohort of school children living within the inner-city London area.](https://niche.org.uk/publications/iron-deficiency-in-a-cohort-of-school-children-living-within-the-inner-city-london-area/) - Iron deficiency in a cohort of school children living within the inner-city London area. - [Erythrocyte sodium-lithium countertransport (SLC) activity and retinol binding protein (RBP) excretion in healthy normotensive subjects.](https://niche.org.uk/publications/erythrocyte-sodium-lithium-countertransport-slc-activity-and-retinol-binding-protein-rbp-excretion-in-healthy-normotensive-subjects/) - Erythrocyte sodium-lithium countertransport (SLC) activity and retinol binding protein (RBP) excretion in healthy normotensive subjects. - [Relationship of Mean Cell Volume and Blood Lead in London Schoolchildren at Low Lead Levels.](https://niche.org.uk/publications/relationship-of-mean-cell-volume-and-blood-lead-in-london-schoolchildren-at-low-lead-levels/) - Relationship of Mean Cell Volume and Blood Lead in London Schoolchildren at Low Lead Levels. - [Benign Hyperbilirubinaemia in Tuvaluan Schoolchildren.](https://niche.org.uk/publications/benign-hyperbilirubinaemia-in-tuvaluan-schoolchildren/) - Benign Hyperbilirubinaemia in Tuvaluan Schoolchildren. - [Blood lead levels and indices of anaemia in London schoolchildren.](https://niche.org.uk/publications/blood-lead-levels-and-indices-of-anaemia-in-london-schoolchildren/) - Blood lead levels and indices of anaemia in London schoolchildren. - [Approaches to optimising access to NICE-approved biologic anti-TNFs for patients with rheumatoid arthritis with moderately active disease](https://niche.org.uk/publications/approaches-to-optimising-access-to-nice-approved-biologic-anti-tnfs-for-patients-with-rheumatoid-arthritis-with-moderately-active-disease-2/) - In response to these changes, we have held discussions with medical teams from across the UK to consider the main implications for implementation of these new recommendations, as well as any differences in approach that may exist at a local level. - [ePHex: a phase 3, double-blind, placebo-controlled, randomized study to evaluate long-term efficacy and safety of Oxalobacter formigenes in patients with primary hyperoxaluria](https://niche.org.uk/publications/ephex-a-phase-3-double-blind-placebo-controlled-randomized-study-to-evaluate-long-term-efficacy-and-safety-of-oxalobacter-formigenes-in-patients-with-primary-hyperoxaluria/) - ePHex: a phase 3, double-blind, placebo-controlled, randomized study to evaluate long-term efficacy and safety of Oxalobacter formigenes in patients with primary hyperoxaluria - [Surface Physiochemistry Affects Protein Adsorption to Stoichiometric and Silicate-Substituted Microporous Hydroxyapatites.](https://niche.org.uk/publications/surface-physiochemistry-affects-protein-adsorption-to-stoichiometric-and-silicate-substituted-microporous-hydroxyapatites/) - Surface Physiochemistry Affects Protein Adsorption to Stoichiometric and Silicate-Substituted Microporous Hydroxyapatites. - [Triglyceride not insulin resistance principally determines sodium-lithium countertransport activity in patients with hyperchylomicronaemia](https://niche.org.uk/publications/triglyceride-not-insulin-resistance-principally-determines-sodium-lithium-countertransport-activity-in-patients-with-hyperchylomicronaemia/) - Triglyceride not insulin resistance principally determines sodium-lithium countertransport activity in patients with hyperchylomicronaemia. - [Blood transcriptomic signature in type-2 biomarker-low severe asthma and asthma control](https://niche.org.uk/publications/blood-transcriptomic-signature-in-type-2-biomarker-low-severe-asthma-and-asthma-control/) - Blood transcriptomic signature in type-2 biomarker-low severe asthma and asthma control - [Multidisciplinary paper on patient blood management in cardiothoracic surgery in the UK: perspectives on practice during COVID-19](https://niche.org.uk/publications/multidisciplinary-paper-on-patient-blood-management-in-cardiothoracic-surgery-in-the-uk-perspectives-on-practice-during-covid-19/) - Multidisciplinary paper on patient blood management in cardiothoracic surgery in the UK: perspectives on practice during COVID-19 - [Approaches to optimising access to NICE-approved biologic anti-TNFs for patients with rheumatoid arthritis with moderately active disease](https://niche.org.uk/publications/approaches-to-optimising-access-to-nice-approved-biologic-anti-tnfs-for-patients-with-rheumatoid-arthritis-with-moderately-active-disease/) - Approaches to optimising access to NICE-approved biologic anti-TNFs for patients with rheumatoid arthritis with moderately active disease - [Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy](https://niche.org.uk/publications/results-from-part-a-of-the-multi-center-double-blind-randomized-placebo-controlled-nefigard-trial-which-evaluated-targeted-release-formulation-of-budesonide-for-the-treatment-of-primary-immunoglob/) - Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy - [Lipidome Analysis in Brain and Peripheral Plasma Following Milk Fat Globule Membrane Supplementation in Rodents](https://niche.org.uk/publications/lipidome-analysis-in-brain-and-peripheral-plasma-following-milk-fat-globule-membrane-supplementation-in-rodents/) - Lipidome Analysis in Brain and Peripheral Plasma Following Milk Fat Globule Membrane Supplementation in Rodents - [Aromatic ointments for the common cold: what does the science say?](https://niche.org.uk/publications/aromatic-ointments-for-the-common-cold-what-does-the-science-say/) - Aromatic ointments for the common cold: what does the science say? - [Exacerbation Profile and Risk Factors in a Type-2-Low Enriched Severe Asthma Cohort: A Clinical Trial to Assess Asthma Exacerbation Phenotypes](https://niche.org.uk/publications/exacerbation-profile-and-risk-factors-in-a-type-2-low-enriched-severe-asthma-cohort-a-clinical-trial-to-assess-asthma-exacerbation-phenotypes/) - Exacerbation Profile and Risk Factors in a Type-2-Low Enriched Severe Asthma Cohort: A Clinical Trial to Assess Asthma Exacerbation Phenotypes - [Azoximer Bromide: Mystery, Serendipity, and Promise](https://niche.org.uk/publications/azoximer-bromide-mystery-serendipity-and-promise/) - Azoximer Bromide: Mystery, Serendipity, and Promise - [The effect of azoximer bromide (Polyoxidonium®) in patients hospitalized with coronavirus disease (COVID-19): an open-label, multicentre, interventional clinical study](https://niche.org.uk/publications/the-effect-of-azoximer-bromide-polyoxidonium-in-patients-hospitalized-with-coronavirus-disease-covid-19-an-open-label-multicentre-interventional-clinical-study/) - The effect of azoximer bromide (Polyoxidonium®) in patients hospitalized with coronavirus disease (COVID-19): an open-label, multicentre, interventional clinical study - [Plasma oxalate and eGFR are correlated in primary hyperoxaluria patients with maintained kidney function-data from three placebo-controlled studies](https://niche.org.uk/publications/plasma-oxalate-and-egfr-are-correlated-in-primary-hyperoxaluria-patients-with-maintained-kidney-function-data-from-three-placebo-controlled-studies/) - Plasma oxalate and eGFR are correlated in primary hyperoxaluria patients with maintained kidney function-data from three placebo-controlled studies - [Human challenge trials the covid-19 vaccines still have much to teach us Response](https://niche.org.uk/publications/human-challenge-trials-the-covid-19-vaccines-still-have-much-to-teach-us-response/) - Human challenge trials the covid-19 vaccines still have much to teach us Response - [Action of Dipeptidyl Peptidase-4 Inhibitors on SARS-CoV-2 Main Protease](https://niche.org.uk/publications/action-of-dipeptidyl-peptidase-4-inhibitors-on-sars-cov-2-main-protease/) - Action of Dipeptidyl Peptidase-4 Inhibitors on SARS-CoV-2 Main Protease - [Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial](https://niche.org.uk/publications/safety-and-efficacy-of-inhaled-nebulised-interferon-beta-1a-sng001-for-treatment-of-sars-cov-2-infection-a-randomised-double-blind-placebo-controlled-phase-2-trial/) - Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial - [Effects of Oxalobacter formigenes in subjects with primary hyperoxaluria Type 1 and end-stage renal disease: a Phase II study](https://niche.org.uk/publications/effects-of-oxalobacter-formigenes-in-subjects-with-primary-hyperoxaluria-type-1-and-end-stage-renal-disease-a-phase-ii-study/) - Effects of Oxalobacter formigenes in subjects with primary hyperoxaluria Type 1 and end-stage renal disease: a Phase II study - [Vector Copy Distribution at a Single-Cell Level Enhances Analytical Characterization of Gene-Modified Cell Therapies](https://niche.org.uk/publications/vector-copy-distribution-at-a-single-cell-level-enhances-analytical-characterization-of-gene-modified-cell-therapies/) - Vector Copy Distribution at a Single-Cell Level Enhances Analytical Characterization of Gene-Modified Cell Therapies - [Lumbar interbody fusion rates with 3D-printed lamellar titanium cages using a silicate-substituted calcium phosphate bone graft](https://niche.org.uk/publications/lumbar-interbody-fusion-rates-with-3d-printed-lamellar-titanium-cages-using-a-silicate-substituted-calcium-phosphate-bone-graft/) - Lumbar interbody fusion rates with 3D-printed lamellar titanium cages using a silicate-substituted calcium phosphate bone graft - [Increasing the incidence of drain-free day-case mastectomies with the use of a fibrin tissue sealant; data from a single surgical center in the United Kingdom](https://niche.org.uk/publications/increasing-the-incidence-of-drain-free-day-case-mastectomies-with-the-use-of-a-fibrin-tissue-sealant-data-from-a-single-surgical-center-in-the-united-kingdom/) - Increasing the incidence of drain-free day-case mastectomies with the use of a fibrin tissue sealant; data from a single surgical center in the United Kingdom - [Evaluation of an increased strut porosity silicate-substituted calcium phosphate, SiCaP EP, as a synthetic bone graft substitute in spinal fusion surgery: a prospective, open-label study](https://niche.org.uk/publications/evaluation-of-an-increased-strut-porosity-silicate-substituted-calcium-phosphate-sicap-ep-as-a-synthetic-bone-graft-substitute-in-spinal-fusion-surgery-a-prospective-open-label-study/) - Evaluation of an increased strut porosity silicate-substituted calcium phosphate, SiCaP EP, as a synthetic bone graft substitute in spinal fusion surgery: a prospective, open-label study - [Pharmacodynamics and pharmacokinetics of fluticasone furoate/vilanterol in healthy Chinese subjects](https://niche.org.uk/publications/pharmacodynamics-and-pharmacokinetics-of-fluticasone-furoate-vilanterol-in-healthy-chinese-subjects/) - Pharmacodynamics and pharmacokinetics of fluticasone furoate/vilanterol in healthy Chinese subjects - [Bariatric surgery in obese older people: Useful or not?](https://niche.org.uk/publications/bariatric-surgery-in-obese-older-people-useful-or-not/) - Bariatric surgery in obese older people: Useful or not? - [Population pharmacokinetic analyses for BC-3781 using phase 2 data from patients with acute bacterial skin and skin structure infections](https://niche.org.uk/publications/population-pharmacokinetic-analyses-for-bc-3781-using-phase-2-data-from-patients-with-acute-bacterial-skin-and-skin-structure-infections/) - Population pharmacokinetic analyses for BC-3781 using phase 2 data from patients with acute bacterial skin and skin structure infections - [Addition of a 5-lipoxygenase-activating protein inhibitor to an inhaled corticosteroid (ICS) or an ICS/long-acting beta-2-agonist combination in subjects with asthma](https://niche.org.uk/publications/addition-of-a-5-lipoxygenase-activating-protein-inhibitor-to-an-inhaled-corticosteroid-ics-or-an-ics-long-acting-beta-2-agonist-combination-in-subjects-with-asthma/) - Addition of a 5-lipoxygenase-activating protein inhibitor to an inhaled corticosteroid (ICS) or an ICS/long-acting beta-2-agonist combination in subjects with asthma - [Drugs in development for the management of dyslipidaemia.](https://niche.org.uk/publications/drugs-in-development-for-the-management-of-dyslipidaemia/) - Drugs in development for the management of dyslipidaemia. - [Midodrine: use and current status in the treatment of hypotension.](https://niche.org.uk/publications/midodrine-use-and-current-status-in-the-treatment-of-hypotension/) - Midodrine: use and current status in the treatment of hypotension. - [Treatment of seborrhoeic dermatitis of the scalp with a topical solution of urea, lactic acid, and propylene glycol (K301): results of two double-blind, randomised, placebo-controlled studies](https://niche.org.uk/publications/treatment-of-seborrhoeic-dermatitis-of-the-scalp-with-a-topical-solution-of-urea-lactic-acid-and-propylene-glycol-k301-results-of-two-double-blind-randomised-placebo-controlled-studies/) - Treatment of seborrhoeic dermatitis of the scalp with a topical solution of urea, lactic acid, and propylene glycol (K301): results of two double-blind, randomised, placebo-controlled studies - [Effects of serum protein on ionic exchange between culture medium and microporous hydroxyapatite and silicate-substituted hydroxyapatite](https://niche.org.uk/publications/effects-of-serum-protein-on-ionic-exchange-between-culture-medium-and-microporous-hydroxyapatite-and-silicate-substituted-hydroxyapatite/) - Effects of serum protein on ionic exchange between culture medium and microporous hydroxyapatite and silicate-substituted hydroxyapatite - [Pharmacokinetics, safety, and tolerability of ascending doses of sublingual fentanyl, with and without naltrexone, in Japanese subjects](https://niche.org.uk/publications/pharmacokinetics-safety-and-tolerability-of-ascending-doses-of-sublingual-fentanyl-with-and-without-naltrexone-in-japanese-subjects/) - Pharmacokinetics, safety, and tolerability of ascending doses of sublingual fentanyl, with and without naltrexone, in Japanese subjects - [Linagliptin, a dipeptidyl peptidase-4 inhibitor in development for the treatment of type 2 diabetes mellitus: a Phase I, randomized, double-blind, placebo-controlled trial of single and multiple escalating doses in healthy adult male Japanese subjects](https://niche.org.uk/publications/linagliptin-a-dipeptidyl-peptidase-4-inhibitor-in-development-for-the-treatment-of-type-2-diabetes-mellitus-a-phase-i-randomized-double-blind-placebo-controlled-trial-of-single-and-multiple-escal/) - Linagliptin, a dipeptidyl peptidase-4 inhibitor in development for the treatment of type 2 diabetes mellitus: a Phase I, randomized, double-blind, placebo-controlled trial of single and multiple escalating doses in healthy adult male Japanese subjects - [Effects of food and antacids on the pharmacokinetics of eltrombopag in healthy adult subjects: two single-dose, open-label, randomized-sequence, crossover studies](https://niche.org.uk/publications/effects-of-food-and-antacids-on-the-pharmacokinetics-of-eltrombopag-in-healthy-adult-subjects-two-single-dose-open-label-randomized-sequence-crossover-studies/) - Effects of food and antacids on the pharmacokinetics of eltrombopag in healthy adult subjects: two single-dose, open-label, randomized-sequence, crossover studies - [Inhibition of dipeptidyl peptidase 4 by BI-1356, a new drug for the treatment of beta-cell failure in type 2 diabetes](https://niche.org.uk/publications/inhibition-of-dipeptidyl-peptidase-4-by-bi-1356-a-new-drug-for-the-treatment-of-beta-cell-failure-in-type-2-diabetes/) - Inhibition of dipeptidyl peptidase 4 by BI-1356, a new drug for the treatment of beta-cell failure in type 2 diabetes - [Pharmacokinetic, pharmacodynamic, efficacy, and safety data from two randomized, double-blind studies in patients with asthma and an in vitro study comparing two dry-powder inhalers delivering a combination of salmeterol 50 microg and fluticasone propionate 250 microg: implications for establishing bioequivalence of inhaled products](https://niche.org.uk/publications/pharmacokinetic-pharmacodynamic-efficacy-and-safety-data-from-two-randomized-double-blind-studies-in-patients-with-asthma-and-an-in-vitro-study-comparing-two-dry-powder-inhalers-delivering-a-combi/) - Pharmacokinetic, pharmacodynamic, efficacy, and safety data from two randomized, double-blind studies in patients with asthma and an in vitro study comparing two dry-powder inhalers delivering a combination of salmeterol 50 microg and fluticasone propionate 250 microg: implications for establishing bioequivalence of inhaled products - [Clinical aspects of the management of HIV lipodystrophy.](https://niche.org.uk/publications/clinical-aspects-of-the-management-of-hiv-lipodystrophy/) - Clinical aspects of the management of HIV lipodystrophy. - [HIV lipodystrophy and its metabolic consequences: implications for clinical practice](https://niche.org.uk/publications/hiv-lipodystrophy-and-its-metabolic-consequences-implications-for-clinical-practice/) - HIV lipodystrophy and its metabolic consequences: implications for clinical practice - [Patterns of asthma-related health care resource use in children treated with montelukast or fluticasone](https://niche.org.uk/publications/patterns-of-asthma-related-health-care-resource-use-in-children-treated-with-montelukast-or-fluticasone/) - Patterns of asthma-related health care resource use in children treated with montelukast or fluticasone - [Efficacy and effectiveness of dihydroartemisinin-piperaquine versus artesunate-mefloquine in falciparum malaria: an open-label randomised comparison](https://niche.org.uk/publications/efficacy-and-effectiveness-of-dihydroartemisinin-piperaquine-versus-artesunate-mefloquine-in-falciparum-malaria-an-open-label-randomised-comparison/) - Efficacy and effectiveness of dihydroartemisinin-piperaquine versus artesunate-mefloquine in falciparum malaria: an open-label randomised comparison - [Patterns of graft and patient survival following renal transplantation and evaluation of serum creatinine as a predictor of survival: a review of data collected from one clinical centre over 34 years](https://niche.org.uk/publications/patterns-of-graft-and-patient-survival-following-renal-transplantation-and-evaluation-of-serum-creatinine-as-a-predictor-of-survival-a-review-of-data-collected-from-one-clinical-centre-over-34-years/) - Patterns of graft and patient survival following renal transplantation and evaluation of serum creatinine as a predictor of survival: a review of data collected from one clinical centre over 34 years - [Triple nucleoside treatment with abacavir plus the lamivudine/zidovudine combination tablet (COM) compared to indinavir/COM in antiretroviral therapy-naïve adults: results of a 48-week open-label, equivalence trial (CNA3014)](https://niche.org.uk/publications/triple-nucleoside-treatment-with-abacavir-plus-the-lamivudine-zidovudine-combination-tablet-com-compared-to-indinavir-com-in-antiretroviral-therapy-naive-adults-results-of-a-48-week-open-label-equ/) - Triple nucleoside treatment with abacavir plus the lamivudine/zidovudine combination tablet (COM) compared to indinavir/COM in antiretroviral therapy-naïve adults: results of a 48-week open-label, equivalence trial (CNA3014) - [A 3-way crossover study to evaluate the pharmacokinetic interaction between nateglinide and diclofenac in healthy volunteers](https://niche.org.uk/publications/a-3-way-crossover-study-to-evaluate-the-pharmacokinetic-interaction-between-nateglinide-and-diclofenac-in-healthy-volunteers/) - A 3-way crossover study to evaluate the pharmacokinetic interaction between nateglinide and diclofenac in healthy volunteers - [A patient with HIV-1 superinfection](https://niche.org.uk/publications/a-patient-with-hiv-1-superinfection/) - A patient with HIV-1 superinfection - [Accumulation of DC-SIGN+CD40+ dendritic cells with reduced CD80 and CD86 expression in lymphoid tissue during acute HIV-1 infection](https://niche.org.uk/publications/accumulation-of-dc-signcd40-dendritic-cells-with-reduced-cd80-and-cd86-expression-in-lymphoid-tissue-during-acute-hiv-1-infection/) - Accumulation of DC-SIGN+CD40+ dendritic cells with reduced CD80 and CD86 expression in lymphoid tissue during acute HIV-1 infection - [HIV and cytomegalovirus viral load and clinical outcomes in AIDS and cytomegalovirus retinitis patients: Monoclonal Antibody Cytomegalovirus Retinitis Trial](https://niche.org.uk/publications/hiv-and-cytomegalovirus-viral-load-and-clinical-outcomes-in-aids-and-cytomegalovirus-retinitis-patients-monoclonal-antibody-cytomegalovirus-retinitis-trial/) - HIV and cytomegalovirus viral load and clinical outcomes in AIDS and cytomegalovirus retinitis patients: Monoclonal Antibody Cytomegalovirus Retinitis Trial - [Erythrocyte Na+/Li+ countertransport and Na+/K+ -2Cl- co-transport in essential hypertension](https://niche.org.uk/publications/erythrocyte-na-li-countertransport-and-na-k-2cl-co-transport-in-essential-hypertension/) - Erythrocyte Na+/Li+ countertransport and Na+/K+ -2Cl- co-transport in essential hypertension - [Enhanced activity of sodium-lithium countertransport in patients with cardiac syndrome X: a potential link between cardiac and metabolic syndrome X](https://niche.org.uk/publications/enhanced-activity-of-sodium-lithium-countertransport-in-patients-with-cardiac-syndrome-x-a-potential-link-between-cardiac-and-metabolic-syndrome-x/) - Enhanced activity of sodium-lithium countertransport in patients with cardiac syndrome X: a potential link between cardiac and metabolic syndrome X - [Dual efficacy of lamivudine treatment in human immunodeficiency virus/hepatitis B virus-coinfected persons in a randomized, controlled study (CAESAR). The CAESAR Coordinating Committee](https://niche.org.uk/publications/dual-efficacy-of-lamivudine-treatment-in-human-immunodeficiency-virus-hepatitis-b-virus-coinfected-persons-in-a-randomized-controlled-study-caesar-the-caesar-coordinating-committee/) - Dual efficacy of lamivudine treatment in human immunodeficiency virus/hepatitis B virus-coinfected persons in a randomized, controlled study (CAESAR). The CAESAR Coordinating Committee - [Na,Li-countertransport and ethnicity](https://niche.org.uk/publications/nali-countertransport-and-ethnicity/) - Na,Li-countertransport and ethnicity - [Transport of phytanic acid on lipoproteins in Refsum disease](https://niche.org.uk/publications/transport-of-phytanic-acid-on-lipoproteins-in-refsum-disease/) - Transport of phytanic acid on lipoproteins in Refsum disease - [Cation transport in Bartter's syndrome](https://niche.org.uk/publications/cation-transport-in-bartters-syndrome/) - Cation transport in Bartter's syndrome - [Influence of plasma phytanic acid levels in Refsum's disease on the behaviour of the erythrocyte membrane sodium-lithium countertransporter](https://niche.org.uk/publications/influence-of-plasma-phytanic-acid-levels-in-refsums-disease-on-the-behaviour-of-the-erythrocyte-membrane-sodium-lithium-countertransporter/) - Influence of plasma phytanic acid levels in Refsum's disease on the behaviour of the erythrocyte membrane sodium-lithium countertransporter - [Kinetic characteristics of the erythrocyte sodium-lithium countertransporter in black normotensive subjects compared with three other ethnic groups](https://niche.org.uk/publications/kinetic-characteristics-of-the-erythrocyte-sodium-lithium-countertransporter-in-black-normotensive-subjects-compared-with-three-other-ethnic-groups/) - Kinetic characteristics of the erythrocyte sodium-lithium countertransporter in black normotensive subjects compared with three other ethnic groups - [Characterization of the erythrocyte sodium-lithium countertransporter: limitations and assumptions of traditional and kinetic methodologies](https://niche.org.uk/publications/characterization-of-the-erythrocyte-sodium-lithium-countertransporter-limitations-and-assumptions-of-traditional-and-kinetic-methodologies/) - Characterization of the erythrocyte sodium-lithium countertransporter: limitations and assumptions of traditional and kinetic methodologies - [Dietary fat and risk of coronary heart disease in men](https://niche.org.uk/publications/dietary-fat-and-risk-of-coronary-heart-disease-in-men/) - Dietary fat and risk of coronary heart disease in men - [Kinetic behavior of the erythrocyte sodium-lithium countertransporter in nonnephropathic diabetic twins](https://niche.org.uk/publications/kinetic-behavior-of-the-erythrocyte-sodium-lithium-countertransporter-in-nonnephropathic-diabetic-twins/) - Kinetic behavior of the erythrocyte sodium-lithium countertransporter in nonnephropathic diabetic twins - [Controversies surrounding erythrocyte sodium-lithium countertransport](https://niche.org.uk/publications/controversies-surrounding-erythrocyte-sodium-lithium-countertransport/) - Controversies surrounding erythrocyte sodium-lithium countertransport - [Angiotensin-converting enzyme (ACE) gene polymorphism and the erythrocyte sodium-lithium countertransporter (SLC) phenotype in hypertension](https://niche.org.uk/publications/angiotensin-converting-enzyme-ace-gene-polymorphism-and-the-erythrocyte-sodium-lithium-countertransporter-slc-phenotype-in-hypertension/) - Angiotensin-converting enzyme (ACE) gene polymorphism and the erythrocyte sodium-lithium countertransporter (SLC) phenotype in hypertension - [Kinetic characteristics of the erythrocyte sodium-lithium countertransporter in subjects with coronary artery disease](https://niche.org.uk/publications/kinetic-characteristics-of-the-erythrocyte-sodium-lithium-countertransporter-in-subjects-with-coronary-artery-disease/) - Kinetic characteristics of the erythrocyte sodium-lithium countertransporter in subjects with coronary artery disease - [Erythrocyte sodium-lithium countertransport activity in non-nephropathic diabetic twins](https://niche.org.uk/publications/erythrocyte-sodium-lithium-countertransport-activity-in-non-nephropathic-diabetic-twins/) - Erythrocyte sodium-lithium countertransport activity in non-nephropathic diabetic twins - [Ethnic origin and hypertension-associated alterations in sodium-lithium countertransport kinetics](https://niche.org.uk/publications/ethnic-origin-and-hypertension-associated-alterations-in-sodium-lithium-countertransport-kinetics/) - Ethnic origin and hypertension-associated alterations in sodium-lithium countertransport kinetics - [Relation of sodium-lithium countertransport activity to markers of cardiovascular risk in normotensive subjects](https://niche.org.uk/publications/relation-of-sodium-lithium-countertransport-activity-to-markers-of-cardiovascular-risk-in-normotensive-subjects/) - Relation of sodium-lithium countertransport activity to markers of cardiovascular risk in normotensive subjects - [Insulin - the cardiologist's viewpoint](https://niche.org.uk/publications/insulin-the-cardiologists-viewpoint/) - Insulin - the cardiologist's viewpoint - [Lack of acute effects of a standardised fat meal or exercise on erythrocyte sodium-lithium countertransport activity](https://niche.org.uk/publications/lack-of-acute-effects-of-a-standardised-fat-meal-or-exercise-on-erythrocyte-sodium-lithium-countertransport-activity/) - Lack of acute effects of a standardised fat meal or exercise on erythrocyte sodium-lithium countertransport activity - [Erythrocyte sodium-lithium countertransport and blood pressure in identical twin pairs discordant for insulin dependent diabetes](https://niche.org.uk/publications/erythrocyte-sodium-lithium-countertransport-and-blood-pressure-in-identical-twin-pairs-discordant-for-insulin-dependent-diabetes/) - Erythrocyte sodium-lithium countertransport and blood pressure in identical twin pairs discordant for insulin dependent diabetes ## Insiders Insights - [Holding a meeting](https://niche.org.uk/insiders_insights/holding-meeting/) - Meetings are a necessary evil but handled badly they can be a terrible waste of time. We provide insights on conducting successful and effective meetings. - [Site Selection](https://niche.org.uk/insider_s_insights/site-selection/) - High functioning investigator sites are essential to the delivery of a successful clinical trial. But not all sites seem able to fulfil their study requirements. - [Insiders Insight Reviews Guide](https://niche.org.uk/insider_s_insights/insiders-insight-reviews-guide/) - The ever-increasing range of scientific knowledge feeds the need for well-conceived reviews that summarise the state-of-play and, through the cited literature, provide an opportunity to dig deeper into the topic of interest. - [Artificial Intelligence in Medical Writing](https://niche.org.uk/insider_s_insights/artificial-intelligence-in-medical-writing/) - Artificial intelligence has reached a point where non-experts can use them to support their work. Should they? - [Investigator Initiated Trials](https://niche.org.uk/insider_s_insights/investigator-initiated-trials/) - Investigator initiated trials offer benefits for investigators, patients and pharmaceutical companies, but they also carry risk. - [Awesome Advisory Boards](https://niche.org.uk/insider_s_insights/awesome-advisory-boards/) - Advisory boards should not be viewed as a stand-alone event, nor will they necessarily address all aspects of a knowledge gap. - [Case Reports](https://niche.org.uk/insider_s_insights/case-reports/) - Case reports are a cornerstone of medical commenting. They typically provide invaluable insight into potentially novel and/or relevant clinical conditions and treatment. - [Good Laboratory Practice](https://niche.org.uk/insider_s_insights/good-laboratory-practice/) - Good Laboratory Practice is a quality system for planning, performing, monitoring, recording, reporting and retaining non-clinical studies. - [Grant Applications](https://niche.org.uk/insider_s_insights/grant-applications/) - Competition for funding is fierce, only a minority of proposals receive support. Grant writing is a skill essential to your average researcher. - [Organising a Professional Conference](https://niche.org.uk/insider_s_insights/organising-a-professional-conference/) - Scientific meetings are at the heart of a scientist’s professional life. The secret behind successful events is a blend of planning and organisation. Crack these and you will be a hard act to follow. - [Responding to Reviewers](https://niche.org.uk/insider_s_insights/responding-to-reviewers/) - A well-constructed response to the reviewers is the key to how well your ‘corrected’ manuscript will be received and whether it will be accepted for publication. - [Investigator's Brochure](https://niche.org.uk/insider_s_insights/investigators-brochure/) - The Investigator's Brochure is a crucial multidisciplinary document in the drug development and regulatory submission process. We provide key learnings to ensure you delivery of a well-constructed, fully compliant document. - [Consensus](https://niche.org.uk/insider_s_insights/consensus/) - Clinical consensus statements reflect opinions drafted by experts for which agreement has been sought on specific clinical challenges. In contrast to clinical practice guidelines, they are more applicable to situations where evidence is limited or lacking, but where there are opportunities to reduce uncertainty and improve quality of care for patients. - [PhD](https://niche.org.uk/insider_s_insights/phd/) - Writing your PhD thesis can be a once-in-a-lifetime opportunity to contribute to your field, relate to your peers with similar interests, and challenge your understanding. While the process is incredibly rewarding, it is best to be appropriately prepared. So we’ve put together a handy guide – so you know exactly what to expect. - [Titles](https://niche.org.uk/insider_s_insights/titles/) - Titles are the first thing readers see, yet often they are addressed at the end of your project, and just as often are the aspect of your work that is given the least attention. - [Self Promotion](https://niche.org.uk/insider_s_insights/self-promotion/) - Long gone are the days of publishing your findings in a journal and simply returning to the bench. We are living in the Information Age – we describe key terms that will help you understand the process of self promotion. - [Bibliometrics Breakdown](https://niche.org.uk/insider_s_insights/bibliometrics-breakdown/) - Do you know your h-index from your m-quotient? Familiarity with bibliometric parameters aids in your assessment of publications. Niche shows you how you may interpret these parameters and employ them effectively. - [Authorship](https://niche.org.uk/insider_s_insights/authorship/) - Authorship can be a source of unethical behaviour and disputes. We provide guidance on how to navigate the authorship minefield. Coming Soon - [Literature Searches](https://niche.org.uk/insider_s_insights/literature-searches/) - Your literature search’s quality and value is wholly dependent on the thought and effort you put into developing your search strategy. We show you how to identify the most appropriate references. - [Key Opinion Leader Identification](https://niche.org.uk/insider_s_insights/key-opinion-leader-identification/) - We summarise what do you need to know to ensure that your next search for ‘thought leaders’ is conducted in an appropriate and considered fashion. - [Training records](https://niche.org.uk/insider_s_insights/training-records/) - Staff working on research studies must be familiar with the requirements of GCP and have up-to-date training records. We provide insights into their content and maintenance. Coming Soon - [Plagiarism](https://niche.org.uk/insider_s_insights/plagiarism-2/) - The issue of plagiarism is of growing concern within biomedical and life science research. Can you navigate it safely? We advise on how to avoid unwarranted accusations of intellectual theft. - [Perfect Press Releases](https://niche.org.uk/insider_s_insights/perfect-press-releases-2/) - Writing a press release is not difficult, though there are conventions that should be followed if you want your material to attract the attention of gate keepers. - [Branding science](https://niche.org.uk/insider_s_insights/branding-science-2/) - A well-chosen name and visual identity for a clinical programme will promote awareness of a clinical intervention and/or practice. We provide here some insights on how. Being Updated - [Better Slide Presentations](https://niche.org.uk/insider_s_insights/better-slide-presentations-2/) - Use the right slide design and your whole presentation will come to life. Follow some simple rules and you will create well-designed presentation slides that effectively communicate your message. - [Poster Presentations](https://niche.org.uk/insider_s_insights/poster-presentations/) - Anyone can read guidelines on what makes a great poster, but can they produce something that looks professional and clearly communicates your message? Niche can and does. - [Amazing Abstracts](https://niche.org.uk/insider_s_insights/amazing-abstracts/) - An abstract is simply a short, standalone summary of your work or paper. Writing abstracts is easy, writing amazing abstracts is not as easy to accomplish. We show you how. - [Clinical Study Reports](https://niche.org.uk/insider_s_insights/clinical-study-reports) - The clinical study report (CSR) is a crucial document in the drug development and regulatory submission process. We provide key learnings to ensure prompt delivery of high quality CSRs. - [Targeted Journal Selection](https://niche.org.uk/insider_s_insights/targeted-journal-selection-2/) - Choosing the wrong journal can result in your publication being delayed. An informed process that targets optimal journal identification will save you time, money and heartache. - [Good publication practice](https://niche.org.uk/insider_s_insights/good-publication-practice-2/) - Authors, collaborators, and organisations share responsibility for developing articles and presentations in a logical and ethical manner. We provide interpretation of good publication guidelines. Being Updated - [Concept Protocols](https://niche.org.uk/insider_s_insights/concept-protocols-2/) - Concept protocols are short, flexible documents that can be reviewed quickly and edited easily. We provide some insights on their efficient design and use. - [Handling Rejection](https://niche.org.uk/insider_s_insights/handling-rejection-2/) - All authors will get some form of rejection from a journal at one time during in their careers. We offer some insights on managing journal submissions successfully. ## Team - [Ammar Moussa](https://niche.org.uk/team/ammar-moussa/) - Ammar has been the Business Manager and IT supervisor at Niche for the last 6 years. - [The Niche Team](https://niche.org.uk/team/the-niche-team/) - At Niche we adopt a set of cultural values that are inherent to everything we do. These translate into a dedication to service that is appreciated by our clients . - [Ruth Hardman](https://niche.org.uk/team/ruth-hardman/) - Ruth has been Finance Director at Niche for 7 of the last 10 years, managing company accounts, contracts and invoicing - [Dr Justin Cook](https://niche.org.uk/team/dr-justin-cook/) - Head of Medical Writing since 2008, Justin joined Niche in 2001. Justin sets Medical Writing strategy in collaboration with other members of the Executive Leadership Team. - [Dr Tim Hardman](https://niche.org.uk/team/dr-tim-hardman/) - Tim established Niche Science & Technology in 1998 following a number of years in clinical trials research and medical writing . - [Dr Laura Lyons](https://niche.org.uk/team/laura-lyons/) - Laura took on the role of Head of Clinical Operations in March 2024, inheriting and expanding our fantastic clinical operations team. Clients and colleagues find Laura to be a friendly and approachable manager. She is knowledgeable and passionate about Clinical Trials and spreads her enthusiasm throughout her team. Laura has over 10 years’ experience ## Case Historie - [Thromboserin](https://niche.org.uk/case-historie/industutrial-new-stem-product-2/) - Thromboserin Ltd. is an ‘innovator’ research company and our mission is to focus primarily on preventing arterial thrombosis. - [Sorriso Pharmaceuticals](https://niche.org.uk/sorri) - Sorriso is a biopharmaceutical company advancing a pipeline of disease-modifying antibodies for the treatment of immune-mediated diseases, including Crohn’s disease and ulcerative colitis. - [Scandinavian Development Services](https://niche.org.uk/sds) - Scandinavian Development Services Life Science was a leading consultancy in the Nordics with regards to regulatory guidance, design of clinical trials and expertise in biostatistics. - [Pulmocide Ltd](https://niche.org.uk/case-historie/industutrial-new-stem-product-4/) - Pulmocide is a company dedicated to developing innovative therapies for serious respiratory diseases, focusing on viral infections and acute respiratory conditions. - [Petrovax](https://niche.org.uk/case-historie/petrovax/) - Petrovax is a Russian biopharmaceutical company established in 1996, specializing in the research, development and production of innovative vaccines, pharmaceuticals and biologics. - [BioKinetic Europe](https://niche.org.uk/case-historie/biokinetic-europe/) - BioKinetic Europe was a fully integrated clinical research organisation with its own purpose-designed clinical pharmacology unit. - [Hammersmith Medicines Research](https://niche.org.uk/case-historie/hammersmith-medicines-research/) - Hammersmith Medicines Research (HMR) is a fully integrated clinical research organisation with its own purpose-designed clinical pharmacology unit. - [Funxional Therapeutics Ltd](https://niche.org.uk/fnx) - Funxional Therapeutics Ltd was a privately-held pharmaceutical start-up. It was set up in 2005 to commercialise the development of broad-spectrum chemokine inhibitors. - [Flatley Discovery Lab](https://niche.org.uk/flatley) - A 30 person not for profit biotech focused exclusively on discovering superior therapeutics for the treatment of cystic fibrosis. - [Assign DMB](https://niche.org.uk/case-histories/assign-dmb/) - Assign’s business model relied on bespoke service providers like Niche to deliver essential aspects of their business delivery model. - [ApaTech](https://niche.org.uk/case-histories/apatech/) - ApaTech was a medical device company that was involved in the manufacturing of orthobiologics, specifically the development of synthetic bone graft materials to enhance bone repair and regeneration. - [MID-Frail Study](https://niche.org.uk/case-histories/mid-frail/) - A significant European research project aimed at evaluating the impact of a multi-modal intervention on frailty and QoL in older adults. - [RASP-UK initiative](https://niche.org.uk/case-histories/rasp/) - The RASP-UK initiative, or Refractory Asthma Stratification Programme, is a UK-based research effort designed to transform the management of severe asthma by adopting a more personalized treatment approach. - [FRAILomic](https://niche.org.uk/case-histories/frailomic/) - The FRAILOMIC initiative was an international research project aimed at improving the understanding, diagnosis and management of frailty in older populations. - [Adaptimmune](https://niche.org.uk/case-histories/adaptimmune/) - Adaptimmune specialises in developing novel therapies for the treatment of resistant tumour types. - [EVERSANA](https://niche.org.uk/case-histories/eversana/) - EVERSANA is a leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organisations, including innovative start-ups - [Orchard Therapeutics plc](https://niche.org.uk/case-histories/orchard/) - Following the acquisition of Strimvelis and associated gene therapy assets by Orchard Therapeutics, our contributions were formally acknowledged as foundational to the success of the regulatory submission. Recognizing the depth of our experience and our commitment to scientific excellence, Orchard Therapeutics re-engaged our team to support the preparation of a new regulatory submission for an - [Synairgen plc](https://niche.org.uk/case-histories/synair/) - Synairgen is a UK-based biopharmaceutical company focused on developing innovative treatments for respiratory diseases, particularly known for its lead product, an inhaled interferon beta (IFN-β) for severe viral lung infections. - [ViiV Healthcare](https://niche.org.uk/case-histories/viiv/) - A specialist pharmaceutical company dedicated to HIV medicines and research with an extensive portfolio of prescription medicines. - [Surface Logix Inc](https://niche.org.uk/case-histories/surface/) - Surface Logix is a drug development company which uses its expertise in biophysical chemistry to create new small molecule drugs with significantly improved pharmacokinetic and pharmacodynamic properties compared with class leaders. - [Recardio Inc](https://niche.org.uk/case-histories/recard/) - Recardio is a life science company that focuses on drug-based regenerative therapeutic modalities for treatments of cardiovascular diseases. - [Cardionetics](https://niche.org.uk/case-histories/cardionetics) - Cardionetics is an innovative hardware and software solutions company specialising in providing intelligent systems for diagnostic, monitoring and screening purposes. - [British Society for Haematology](https://niche.org.uk/case-histories/british-society-for-haematology) - The British Society for Haematology (BSH), the UK’s largest haematology organisation, promotes excellence within the field and supports the professional development of over 3000 members. - [Cleothena Enterprises Pty Ltd](https://niche.org.uk/case-histories/cleo/) - Cleothena Enterprises Pty Ltd. is a forward-thinking biotechnology company focused on advancing innovative therapeutic solutions through precision science, robust clinical strategy and streamlined regulatory engagement. Specialising in the development and communication of high-quality clinical and scientific materials—such as clinical protocols, Investigator’s Brochures and regulatory documentation—Cleothena supports biopharmaceutical organisations in accelerating their development programs with clarity, - [DemeRx](https://niche.org.uk/case-histories/deme/) - DemeRx is a US-based clinical stage pharmaceutical development company advancing drug candidates as therapies for addiction. It is currently evaluating patient data which demonstrate that a single dose of ibogaine may be sufficient to detoxify patients with opioid dependence and diminish drug cravings for extended time periods. As part of their clinical plan, DemeRx is - [ReCode Therapeutics Inc.](https://niche.org.uk/case-histories/recode/) - ReCode Therapeutics is a US-based, clinical-stage genetic medicines company is developing therapeutics for genetically defined diseases with no existing treatment options including primary ciliary dyskinesia and cystic fibrosis. - [VectivBio](https://niche.org.uk/case-historie/industutrial-new-stem-product-5/) - VectivBio has evolved from a small biotech in engaged in early development into an organisation actively planning and rapidly approaching its own submissions for global commercialisation. - [iOnctura](https://niche.org.uk/ionctura) - iOnctura is a clinical-stage biopharmaceutical company that benefited from our history with oncology indications, to consolidate an evolving study design and manage complex data outputs to present a comprehensive package. - [HOOKIPA Pharma](https://niche.org.uk/case-historie/hookipa-pharma/) - HOOKIPA Pharma is a small but ambitious company with a pioneering vision for their arenavirus platform - [Nanomerics](https://niche.org.uk/case-historie/industutrial-new-stem-product-3/) - Nanomerics’ mission is to deliver augmented medicines with improved activity and fewer associated side effects through the application of materials science. - [Nabriva Therapeutics](https://niche.org.uk/case-histories/nabriv/) - Nabriva Therapeutics was incorporated as a spin-off from Sandoz GmbH Antibiotics Research Institute (ABRI) in Vienna. The new organisation included small molecule assets, including pleuromutilin structure activity relationships (SAR) knowledge, and focused on synthesis of pleuromutilins for systemic human use. Following identification of their lead compound lefamulin and based on its clinical results for acute - [Erytech Pharma SA](https://niche.org.uk/case-histories/erythech/) - Erytech Pharma SA is a clinical-stage biopharmaceutical company based in Lyon, France, best known for its proprietary ERYCAPS® red cell encapsulation platform, which it uses to produce red cell-based therapeutics to treat patients with rare forms of cancer and orphan diseases. Erytech’s lead product candidate, eryaspase (red cells encapsulating asparaginase), is currently in Phase 3 - [Astex Pharmaceuticals](https://niche.org.uk/case-histories/astex/) - Astex employs its proprietary Pyramid™ platform to develop innovative therapies targeting challenging or “intractable” diseases. - [RespiVert Ltd](https://niche.org.uk/case-historie/respivert/) - Respivert was a clinical-stage biopharmaceutical company that benefited from our history and experience with asthma. ## podcast new - [The Authenticity Advantage in Sales](https://niche.org.uk/the-authenticity-advantage-in-sales/) - [Talking Sense About Science](https://niche.org.uk/talking-sense-about-science/) - [Predatory Science Publishers Profit Over Progress?](https://niche.org.uk/predatory-science-publishers_-profit-over-progress/) - [Embracing Praise Understanding and Overcoming Resistance](https://niche.org.uk/embracing-praise_-understanding-and-overcoming-resistance/) - [Efficient Manuscript Editing A Three-Phase Workflow](https://niche.org.uk/efficient-manuscript-editing_-a-three-phase-workflow/) - [Big Science vs. Small Science: Efficiency and Adaptability](https://niche.org.uk/bigscience) - [Artificial Intelligence Mitigating the Risks](https://niche.org.uk/artificial-intelligence_-mitigating-the-risks/) - [The Paradox of Unshackled Progress](https://niche.org.uk/the-paradox-of-unshackled-progress/) - [The Power of Visuals Engaging Readers with Images](https://niche.org.uk/the-power-of-visuals_-engaging-readers-with-images/) - [Clinical Study Reports](https://niche.org.uk/issue-22/) - [AI and PubMed Contrasting Contributions to Medical Advancement](https://niche.org.uk/ai-and-pubmed_-contrasting-contributions-to-medical-advancement/) - [Optimizing Your Monitor for Maximum Productivity](https://niche.org.uk/optimizing-your-monitor-for-maximum-productivity/) - [Pre-Writing Strategies for Focused and Effective Writing](https://niche.org.uk/pre-writing-strategies-for-focused-and-effective-writing/) - [The Art and Science of Effective Feedback](https://niche.org.uk/the-art-and-science-of-effective-feedback/) - [The Importance of Sentence Length in Writing](https://niche.org.uk/the-importance-of-sentence-length-in-writing/) - [The Power and Psychology of Making Lists](https://niche.org.uk/the-power-and-psychology-of-making-lists/) - [Navigating Journal Submission Rejection An Insider's Guide](https://niche.org.uk/issue-2-navigating-journal-submission-rejection_-an-insider_s-guide/) - [Concept Protocols: An Insider's Guide to Efficient Study Design](https://niche.org.uk/issue-3-concept-protocols_-an-insider_s-guide-to-efficient-study-design/) - [Targeted Journal Selection](https://niche.org.uk/issue-5-targeted-journal-selection_-an-insider_s-guide/) - [Crafting Amazing Abstracts](https://niche.org.uk/issue-7-s-guide/) - [Creating Effective Research Poster Presentations](https://niche.org.uk/issue-8-creating-effective-research-poster-presentations/) - [Better Slide Presentations](https://niche.org.uk/issue-9-s-guide/) - [Good Laboratory Practice](https://niche.org.uk/issue-27-s-insight/) - [Effective Meetings: Best Practices](https://niche.org.uk/issue-1-effective-meetings/) ## Audio Player - [Clinical Study Reports_ An Insider's Guide to Preparation](https://niche.org.uk/audioplayer/clinical-study-reports_-an-insiders-guide-to-preparation/) - [Better Slide Presentations](https://niche.org.uk/audioplayer/better-slide-presentations/) - [Effective Meetings: Best Practices](https://niche.org.uk/audioplayer/effective-meetings-best-practices/) - [Issue 32 Guiding Principles for Writing Effective Review Articles](https://niche.org.uk/audioplayer/issue-32-guiding-principles-for-writing-effective-review-articles/) - [Issue 31 AI in Medical Writing_ Insider Insights and Ethical Considerations](https://niche.org.uk/audioplayer/issue-31-ai-in-medical-writing_-insider-insights-and-ethical-considerations/) - [issue 30 's Guide](https://niche.org.uk/audioplayer/issue-30-s-guide/) - [issue 29 's Guide](https://niche.org.uk/audioplayer/issue-29-s-guide/) - [Issue 28 Crafting Effective Case Reports for Medical Publication](https://niche.org.uk/audioplayer/issue-28-crafting-effective-case-reports-for-medical-publication/) - [issue 27 's Insight](https://niche.org.uk/audioplayer/issue-27-s-insight/) - [Issue 26 Grants_ From Wow to Pow - Success Factors](https://niche.org.uk/audioplayer/issue-26-grants_-from-wow-to-pow-success-factors/) - [Issue 25 Organising a Professional Conference_ An Insider’s Insight](https://niche.org.uk/audioplayer/issue-25-organising-a-professional-conference_-an-insiders-insight/) - [issue 23 's Insight](https://niche.org.uk/audioplayer/issue-23-s-insight/) - [issue 22 's Guide](https://niche.org.uk/audioplayer/issue-22-s-guide/) - [Issue 18 Amplify Your Science_ A Guide to Dissemination and Legacy](https://niche.org.uk/audioplayer/issue-18-amplify-your-science_-a-guide-to-dissemination-and-legacy/) - [issue 15 's Guide](https://niche.org.uk/audioplayer/issue-15-s-guide/) - [issue 9 's Guide](https://niche.org.uk/audioplayer/issue-9-s-guide/) - [Issue 8 Creating Effective Research Poster Presentations](https://niche.org.uk/audioplayer/issue-8-creating-effective-research-poster-presentations/) - [issue 7 's Guide](https://niche.org.uk/audioplayer/issue-7-s-guide/) - [Issue 5 Targeted Journal Selection_ An Insider_s Guide](https://niche.org.uk/audioplayer/issue-5-targeted-journal-selection_-an-insider_s-guide/) - [Issue 3 Concept Protocols_ An Insider_s Guide to Efficient Study Design](https://niche.org.uk/audioplayer/issue-3-concept-protocols_-an-insider_s-guide-to-efficient-study-design/) - [Issue 2 Navigating Journal Submission Rejection_ An Insider_s Guide](https://niche.org.uk/audioplayer/issue-2-navigating-journal-submission-rejection_-an-insider_s-guide/) - [Big Science vs. Small Science_ Efficiency and Adaptability](https://niche.org.uk/audioplayer/3338/) - [Work Smarter_ Neuroscience of Sustainable Productivity](https://niche.org.uk/audioplayer/work-smarter_-neuroscience-of-sustainable-productivity/) - [The Science and Art of First Impressions](https://niche.org.uk/audioplayer/the-science-and-art-of-first-impressions/) - [The Power of Visuals_ Engaging Readers with Images](https://niche.org.uk/audioplayer/the-power-of-visuals_-engaging-readers-with-images/) - [The Power and Psychology of Making Lists](https://niche.org.uk/audioplayer/the-power-and-psychology-of-making-lists/) - [The Paradox of Unshackled Progress](https://niche.org.uk/audioplayer/the-paradox-of-unshackled-progress/) - [The Importance of Sentence Length in Writing](https://niche.org.uk/audioplayer/the-importance-of-sentence-length-in-writing/) - [The Authenticity Advantage in Sales](https://niche.org.uk/audioplayer/the-authenticity-advantage-in-sales/) - [The Art and Science of Effective Feedback](https://niche.org.uk/audioplayer/the-art-and-science-of-effective-feedback/) - [Talking Sense About Science](https://niche.org.uk/audioplayer/talking-sense-about-science/) - [Predatory Science Publishers_ Profit Over Progress?](https://niche.org.uk/audioplayer/predatory-science-publishers_-profit-over-progress/) - [Pre-Writing Strategies for Focused and Effective Writing](https://niche.org.uk/audioplayer/pre-writing-strategies-for-focused-and-effective-writing/) - [Optimizing Your Monitor for Maximum Productivity](https://niche.org.uk/audioplayer/optimizing-your-monitor-for-maximum-productivity/) - [Embracing Praise_ Understanding and Overcoming Resistance](https://niche.org.uk/audioplayer/embracing-praise_-understanding-and-overcoming-resistance-2/) - [Efficient Manuscript Editing_ A Three-Phase Workflow](https://niche.org.uk/audioplayer/efficient-manuscript-editing_-a-three-phase-workflow/) - [Artificial Intelligence_ Mitigating the Risks](https://niche.org.uk/audioplayer/artificial-intelligence_-mitigating-the-risks/) - [AI and PubMed_ Contrasting Contributions to Medical Advancement](https://niche.org.uk/audioplayer/ai-and-pubmed_-contrasting-contributions-to-medical-advancement/) - [Handling Rejection podcast](https://niche.org.uk/audioplayer/handling-rejection-podcast/) - [Embracing Praise_ Understanding and Overcoming Resistance](https://niche.org.uk/audioplayer/embracing-praise_-understanding-and-overcoming-resistance/) ## Categories - [Uncategorized](https://niche.org.uk/category/uncategorized/) - [Medical Writing](https://niche.org.uk/category/medical-writing/) - [MID-Frail](https://niche.org.uk/category/mid-frail/) - [Publication](https://niche.org.uk/category/publication/) - [Guidance](https://niche.org.uk/category/guidance/) - [Newsletter](https://niche.org.uk/category/newsletter/) - [Frailomic](https://niche.org.uk/category/frailomic/) - [RASP-UK](https://niche.org.uk/category/rasp-uk/) - [Insider's Insight](https://niche.org.uk/category/insiders-insight/) - [Science](https://niche.org.uk/category/science/) - [Clinical](https://niche.org.uk/category/clinical/) - [Christmas](https://niche.org.uk/category/christmas/) - [Halloween](https://niche.org.uk/category/halloween/) - [Research](https://niche.org.uk/category/research/) - [Life and events](https://niche.org.uk/category/life-and-events/) - [Regulatory](https://niche.org.uk/category/regulatory/) - [Growth](https://niche.org.uk/category/growth/) - [Podcast](https://niche.org.uk/category/podcast/) - [Insider Podcast](https://niche.org.uk/category/insider-podcast/) - [April Fools](https://niche.org.uk/category/april-fools/) - [Business](https://niche.org.uk/category/business/) ## Tags - [Regulatory](https://niche.org.uk/tag/regulatory/) - [Medical Writing](https://niche.org.uk/tag/medical-writing/) - [Skills](https://niche.org.uk/tag/skills/) - [Insider’s Insight](https://niche.org.uk/tag/insiders-insight/) - [Clinical](https://niche.org.uk/tag/clinical/) - [Newsletter](https://niche.org.uk/tag/newsletter/) - [Publication](https://niche.org.uk/tag/publication/) - [News](https://niche.org.uk/tag/news/) - [Comment](https://niche.org.uk/tag/comment/) ## CH Categories - [Investigator’s Brochure](https://niche.org.uk/case-historie-cat/investigators-brochure/) - [Manuscripts](https://niche.org.uk/case-historie-cat/manuscripts/) - [Abstract](https://niche.org.uk/case-historie-cat/abstract/) - [Posters](https://niche.org.uk/case-historie-cat/posters/) - [Clinical Study Reports](https://niche.org.uk/case-historie-cat/clinical-study-reports/) - [Narratives](https://niche.org.uk/case-historie-cat/narratives/) - [Monitoring](https://niche.org.uk/case-historie-cat/monitoring/) - [Medical writing](https://niche.org.uk/case-historie-cat/medical-writing/) - [Publication](https://niche.org.uk/case-historie-cat/publication/) - [Regulatory Affairs](https://niche.org.uk/case-historie-cat/regulatory-affairs/) - [Protocols](https://niche.org.uk/case-historie-cat/protocols/) - [Clinical Project Management](https://niche.org.uk/case-historie-cat/clinical-project-management/) - [Medical Affairs](https://niche.org.uk/case-historie-cat/medical-affairs/) - [Publication Planning](https://niche.org.uk/case-historie-cat/publication-planning/) - [IMPD](https://niche.org.uk/case-historie-cat/impd/) - [ILAP](https://niche.org.uk/case-historie-cat/ilap/) - [Scientific Advice](https://niche.org.uk/case-historie-cat/scientific-advice/) - [Legal Rep](https://niche.org.uk/case-historie-cat/legal-rep/) - [MAA/NDA](https://niche.org.uk/case-historie-cat/maa-nda/) ## CH Tags - [Clinical Operations](https://niche.org.uk/ch-tags/clinical-operations/) - [Medical writing](https://niche.org.uk/ch-tags/medical-writing/) - [Regulatory Affairs](https://niche.org.uk/ch-tags/regulatory-affairs/) - [Legal Rep](https://niche.org.uk/ch-tags/legal-rep/) - [Publication planning](https://niche.org.uk/ch-tags/publication-planning/) - [Programme Coordination](https://niche.org.uk/ch-tags/programme-coordination/) - [Business](https://niche.org.uk/ch-tags/business/) ## Category Inserders Insights - [Publication](https://niche.org.uk/category-inserders-insights/publication/) - [Business](https://niche.org.uk/category-inserders-insights/business/) - [Regulatory](https://niche.org.uk/category-inserders-insights/regulatory/) - [Clinical](https://niche.org.uk/category-inserders-insights/clinical/) - [Publication planning](https://niche.org.uk/category-inserders-insights/publication-planning/) - [Clinical study report](https://niche.org.uk/category-inserders-insights/clinical-study-report/) - [Poster](https://niche.org.uk/category-inserders-insights/poster/) - [Medical writing](https://niche.org.uk/category-inserders-insights/medical-writing/) - [Skills](https://niche.org.uk/category-inserders-insights/skills/) ## Tags Inserders Insights - [Regulatory](https://niche.org.uk/tags_inserders_insights/regulatory/) - [Skills](https://niche.org.uk/tags_inserders_insights/skills/) - [Medical writing](https://niche.org.uk/tags_inserders_insights/medical-writing/) - [Clinical](https://niche.org.uk/tags_inserders_insights/clinical/) - [Publication Planning](https://niche.org.uk/tags_inserders_insights/publication-planning/) - [Clinical Operations](https://niche.org.uk/tags_inserders_insights/clinical-operations/) ## Publication Name - [Acknowledged](https://niche.org.uk/publications_name/acknowledged/) - [Niche Manuscript](https://niche.org.uk/publications_name/niche-manuscript/) ## Publishing Year - [1998](https://niche.org.uk/publishing_year/1998/) - [1999](https://niche.org.uk/publishing_year/1999/) - [2000](https://niche.org.uk/publishing_year/2000/) - [2001](https://niche.org.uk/publishing_year/2001/) - [2002](https://niche.org.uk/publishing_year/2002/) - [2003](https://niche.org.uk/publishing_year/2003/) - [2004](https://niche.org.uk/publishing_year/2004/) - [2005](https://niche.org.uk/publishing_year/2005/) - [2006](https://niche.org.uk/publishing_year/2006/) - [2007](https://niche.org.uk/publishing_year/2007/) - [2008](https://niche.org.uk/publishing_year/2008/) - [2009](https://niche.org.uk/publishing_year/2009/) - [2010](https://niche.org.uk/publishing_year/2010/) - [2011](https://niche.org.uk/publishing_year/2011/) - [2012](https://niche.org.uk/publishing_year/2012/) - [2013](https://niche.org.uk/publishing_year/2013/) - [2014](https://niche.org.uk/publishing_year/2014/) - [2015](https://niche.org.uk/publishing_year/2015/) - [2016](https://niche.org.uk/publishing_year/2016/) - [2017](https://niche.org.uk/publishing_year/2017/) - [2018](https://niche.org.uk/publishing_year/2018/) - [2019](https://niche.org.uk/publishing_year/2019/) - [2020](https://niche.org.uk/publishing_year/2020/) - [2021](https://niche.org.uk/publishing_year/2021/) - [2022](https://niche.org.uk/publishing_year/2022/) - [2023](https://niche.org.uk/publishing_year/2023/) - [1994](https://niche.org.uk/publishing_year/1994/) - [1996](https://niche.org.uk/publishing_year/1996/) - [1995](https://niche.org.uk/publishing_year/1995/) - [1992](https://niche.org.uk/publishing_year/1992/) ## Article Type - [Primary manuscript](https://niche.org.uk/article-type/primary-manuscript/) - [Review](https://niche.org.uk/article-type/review/) - [Poster](https://niche.org.uk/article-type/poster/) - [Case History](https://niche.org.uk/article-type/case-history/) - [Letter](https://niche.org.uk/article-type/letter/) ## Category insider Insights - [Business](https://niche.org.uk/category-insider-insights/business/)