美国食品药品监督管理局对甾体避孕药非临床测试的要求。
FDA requirements for nonclinical testing of contraceptive steroids.
作者信息
Jordan A
机构信息
Division of Metabolism and Endocrine Drug Products, Food and Drug Administration.
出版信息
Contraception. 1992 Dec;46(6):499-509. doi: 10.1016/0010-7824(92)90114-9.
PMID:1493710
Abstract
Written guidelines for the preclinical testing of contraceptive steroids have not been revised since 1968 despite the fact that many important changes have been implemented by the FDA's Division of Metabolism and Endocrine Drug Products. This paper describes the new preclinical testing requirements and the rationale for their implementation.
摘要
尽管美国食品药品监督管理局代谢与内分泌药品司已实施了许多重大变革，但自1968年以来，甾体避孕药临床前测试的书面指南一直未修订。本文描述了新的临床前测试要求及其实施的基本原理。
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