Fed Regist. 2001 Jul 13;66(135):36791-2.
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S7A Safety Pharmacology Studies for Human Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides a definition, general principles, and recommendations for the nonclinical safety pharmacology studies. The guidance is intended to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources.
美国食品药品监督管理局（FDA）宣布发布一份题为《人用药品的S7A安全药理学研究》的指南。该指南是在人用药品注册技术要求国际协调会议（ICH）的主持下制定的。该指南提供了非临床安全药理学研究的定义、一般原则和建议。该指南旨在帮助保护临床试验参与者和使用上市产品的患者免受药品潜在不良反应的影响，同时避免不必要地使用动物和其他资源。
