摘要
评价药物对人类睾丸毒性的难度较大。为此,FDA于2015年7月发布了《药物开发期间的睾丸毒性评价指导原则》,提供了非临床和临床研究方法及其结果评价。我国尚无相关指导原则。本文介绍FDA该指导原则的主要内容,期望对我国相关研究和监管工作有帮助。
It is difficult to evaluate testicular toxicity of drug in humans.To that end,FDA issued ＂Testicular Toxicity：Evaluation During Drug Development Guidance＂ in July 2015,providing nonclinical and clinical research methods and the result evaluation.There is no such guidance in China.This paper introduces the main content of the guidance of FDA,and it is expected to guide the research and supervision in China.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2016年第1期103-106,共4页
Chinese Journal of Clinical Pharmacology and Therapeutics
