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

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Bibliographic Details
Published in:	British journal of clinical pharmacology Vol. 84; no. 7; pp. 1401 - 1409
Main Authors:	Gerven, Joop, Bonelli, Milton
Format:	Journal Article
Language:	English
Published:	England John Wiley and Sons Inc 01.07.2018
Subjects:	Animals Clinical Trials, Phase I as Topic - ethics Clinical Trials, Phase I as Topic - legislation & jurisprudence Clinical Trials, Phase I as Topic - standards Dose-Response Relationship, Drug Drug Approval - legislation & jurisprudence Drug Evaluation, Preclinical - standards Drugs, Investigational - pharmacology Ema Guidelines Series Europe European Union - organization & administration Healthy Volunteers Humans Models, Animal Nontherapeutic Human Experimentation - ethics Nontherapeutic Human Experimentation - legislation & jurisprudence Nontherapeutic Human Experimentation - standards Practice Guidelines as Topic Research Design - standards Europe
ISSN:	0306-5251, 1365-2125, 1365-2125
Online Access:	Get full text
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Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0306-5251 1365-2125 1365-2125
DOI:	10.1111/bcp.13550