Fed Regist. 2010 Jan 21;75(13):3471-2.
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for 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, which is a revision of an existing guidance, discusses the types of nonclinical studies, their scope and duration, and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals. The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources.
美国食品药品监督管理局（FDA）宣布发布一份题为《M3(R2) 用于人类临床试验和药品上市许可的非临床安全性研究》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。此指南是对现有指南的修订，讨论了非临床研究的类型、范围和持续时间，以及它们与人类临床试验开展和药品上市许可的关系。该指南旨在促进临床试验的及时开展，并减少动物及其他药物研发资源的不必要使用。
