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

MedPharm’s CSO and University of Reading Professor co-author new book on dermal formulation development

MedPharm’s Chief Scientific Officer and Co-Founder, Professor Marc Brown and University of Reading’s Professor Adrian Williams have co-authored the new book: ‘The Art and Science of Dermal Formulation Development”. It is the latest addition to ‘Drugs and the Pharmaceutical Sciences’, a series of textbooks and monographs published by CRC Press.
More info >>

White Papers

The Rare Disease Patients Experience

When planning a clinical trial for a rare disease, it is important to have a holistic understanding of your patient population. You want to be aware of where your patients are coming from, and what it is like to walk in their shoes. These patients need your trial just as much as you need them; even from the earliest stages, conceptualize your rare disease trial as an altruistic relationship between the patient population and your study.
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