美國食品藥品監(jiān)督管理局(FDA)于2015年9月發(fā)布了"藥物內分泌毒性非臨床評價指導原則",介紹如何從非臨床安全性試驗標準組合試驗提取藥物內分泌毒性信息,并介紹根據(jù)哪些因素判斷是否需要增加試驗,進一步揭示其內分泌毒性特點。我國目前尚無這樣的指導原則,介紹該指導原則的主要內容,期待對我國這方面的研究和政府監(jiān)管有所幫助。

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.