期刊
REGULATORY TOXICOLOGY AND PHARMACOLOGY
卷 64, 期 3, 页码 345-349出版社
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yrtph.2012.09.002
关键词
Predictive value; Animal studies; Non-clinical drug development; Serious adverse reactions; Pharmacovigilance; Regulatory science
资金
- Top Institute Pharma [T6-301]
- Amgen
- Johnson Johnson
- Roche
- Sandoz
- Hospira
The value of animal studies to assess drug safety is unclear because many such studies are biased and have methodological shortcomings. We studied whether post-marketing serious adverse reactions to small molecule drugs could have been detected on the basis of animal study data included in drug registration files. Of 93 serious adverse reactions related to 43 small molecule drugs, only 19% were identified in animal studies as a true positive outcome, which suggests that data from animal studies are of limited value to pharmacovigilance activities. Our study shows that drug registration files can be used to study the predictive value of animal studies and that the value of animal studies in all stages of the drug development should be investigated in a collaborative endeavour between regulatory authorities, industry, and academia. (C) 2012 Elsevier Inc. All rights reserved.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据