Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products
Author:
Affiliation:
1. Central Committee on Research Involving Human Subjects CCMO; The Hague The Netherlands
2. Human Medicines Research and Development Support Division; European Medicines Agency; London UK
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1111/bcp.13550/fullpdf
Reference32 articles.
1. European Medicines Agency Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products (EMEA/CHMP/SWP/28367/07 Rev. 1) 2017
2. Analysis of integrated clinical trial protocols in early phases of medicinal product development;Fruhner;Eur J Clin Pharmacol,2017
3. Expert group on phase one clinical trials (chairman: Professor Gordon W. Duff) expert group on phase one clinical trials: final report 2006 TSO (the stationary office)
4. The TeGenero incident and the Duff Report conclusions: a series of unfortunate events or an avoidable event?;Horvath;Toxicol Pathol,2009
5. Establishing risk of human experimentation with drugs: lessons from TGN1412;Kenter;Lancet,2006
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