Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.
作者信息
van Gerven Joop, Bonelli Milton
机构信息
Central Committee on Research Involving Human Subjects CCMO, The Hague, The Netherlands.
Human Medicines Research and Development Support Division, European Medicines Agency, London, UK.
出版信息
Br J Clin Pharmacol. 2018 Jul;84(7):1401-1409. doi: 10.1111/bcp.13550. Epub 2018 May 30.
Abstract
摘要
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