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[摘要]
美国食品药品监督管理局(FDA)于2015年9月发布了"药物内分泌毒性非临床评价指导原则",介绍如何从非临床安全性试验标准组合试验提取药物内分泌毒性信息,并介绍根据哪些因素判断是否需要增加试验,进一步揭示其内分泌毒性特点。我国目前尚无这样的指导原则,介绍该指导原则的主要内容,期待对我国这方面的研究和政府监管有所帮助。
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[Abstract]
FDA issued "Nonclinical Evaluation of Endocrine-Related Drug Toxicity Guidance" in September, 2015. The guidance introduced how the information of endocrine toxicity is extracted from a standard battery of nonclinical safety tests, and according to which factors determine whether the need to increase tests, to further reveal the characteristics of the endocrine toxicity. However there is no such guidance in our country. This article introduces the main content of the guidance, and is expected to help the research and government regulation in our country.
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