关于实施药品临床试验管理规范的探讨  

Discussion on Conducting Clinical Trial in Accordance with the Guideline for GCP

作　　者：林梅 王麟达 

机构地区：[1]上海市药品监督管理局,200021

出　　处：《中国药事》2002年第10期608-610,共3页Chinese Pharmaceutical Affairs

摘　　要：临床试验是新药开发不可缺少的环节。临床试验中遵循药品临床试验管理规范 (GCP)的原则有助于保护受试者的合法权益及健康安全 ,并确保临床试验结果科学可靠。本文对我国目前药品临床试验实施GCP的现状及解决问题的对策作了一些探讨。Clinical trial is an essential process in new drug R&D. Conducting clinical trial in accordance with guideline for GCP (Good Clinical Practice) provides assistance on the licit rights as well as the safety of the subjects, and it can also assure the reliance of the dossier. The currency on clinical trial conducting and the tactics to solve the problem have been studied.

关 键 词：临床试验 药品临床试验管理规范 新药开发 医药事业 

分 类 号：R95[医药卫生—药学]