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《药物临床试验质量管理规范》(修订稿)解读 被引量:20

Interpretation of “Good Clinical Practice(revised draft) ”
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摘要 2015年2月6日,国家食品药品监督管理总局公开发布关于征求《药物临床试验质量管理规范》修订稿意见的通知,向药物临床试验机构、研发企业以及监管人员等各有关方征求意见。本文对该规范进行解读,指出药物临床试验及监管的新动向并提出相关思考。 On February 6,2015,CFDA issued a notice to solicit public about "Good Clinical Practice( revised draft) ". Based on years of drug clinical trial experience,we interpreted the draft,pointed out the new trend of drug clinical trial and administrative supervision,and put forward the related considerations.
出处 《中国新药杂志》 CAS CSCD 北大核心 2015年第15期1747-1749,1785,共4页 Chinese Journal of New Drugs
基金 国家"十二五"创新药物研究开发技术平台建设(2012ZX09303-010002)
关键词 药物临床试验质量管理规范 解读 Good Clinical Practice interpretation
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