Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products-Reference-Cited by-同舟云学术

Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

Published:2018-05-30 Issue:7 Volume:84 Page:1401-1409
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

van Gerven Joop¹^ORCID,Bonelli Milton²^ORCID

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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