spacer
home > ict > winter 2019 > advancing expansion
PUBLICATIONS
International Clinical Trials

Advancing Expansion

The UK has significant experience in first-in-human (FIH) clinical trials and has performed almost a quarter of the total of 2,206 FIH studies in the EU between 2005 and 2017 (Figure 1). Furthermore, the number of FIH trials conducted in the UK continues to increase; 69 out of 143 (48%) Phase 1 trials in 2016 were FIH, whereas, in 2017, this number grew to 105 out of 167 (63%) (1). The collective experience of regulators, clinical Phase 1 units, and FIH principal investigators in the last couple of decades has played a significant role in the development of guidelines for FIH/early phase clinical trials. However, two events come to the forefront of any early clinical developer’s mind in relation to the guidance issued by the EMA in this area.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Dr Simon Hutchings has over 11 years of experience in the drug development process, including preclinical pharmacology/toxicology, Phase 1 (including first-in-human) pharmacology/ PK studies, and investigator-led Phase 2 and 3 trials. In addition to undergraduate and postgraduate qualifications in pharmacology, he also holds a Certificate in Human Pharmacology from the Faculty of Pharmaceutical Medicine at the Royal College of Physicians, UK. Simon has extensive practical experience and scientific knowledge of the design, management, and reporting of clinical development projects.
spacer
Dr Simon Hutchings
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Turkish Cargo awarded with the prestigious Cargo Airline of the Year 2019 prize by the global logistics industry

 Maintaining its upward trend, Turkish Cargo was granted with the ‘Cargo Airline of the Year 2019’ award, called as the Oscar of the global logistics industry, by the global air cargo sector readers of the Air Cargo News magazine.
More info >>

White Papers

Bringing more control to temperature-sensitive logistics

UPS Supply Chain Solutions

By 2016, world sales of cold-chain drugs and biologics such as vaccines and blood plasma products will near $240 billion1. The increase has led to a surge in discussion about how to protect these products throughout the transportation logistics cycle. Industry experts are recommending that the term “cold chain” be eliminated from rules, guidance and best-practice documents. “Cold chain” now includes a broader spectrum of temperature ranges, such as controlled room temperature (CRT). This white paper focuses on the initial steps required to establish a temperature-sensitive supply chain.
More info >>

 
Industry Events

The Universe of Pre-filled Syringes and Injection Devices

22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel

PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement