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中药上市后临床再评价及Ⅳ期临床试验的基本要求
引用本文:谢雁鸣,王燕平,田峰,王永炎.中药上市后临床再评价及Ⅳ期临床试验的基本要求[J].中国中药杂志,2011,36(20):2764-2767.
作者姓名:谢雁鸣  王燕平  田峰  王永炎
作者单位:1. 中国中医科学院中医临床基础医学研究所,北京,100700
2. 中国中医科学院博士后流动站,北京,100700
基金项目:国家"重大新药创制"科技重大专项(2009ZX09502-030);中国中医科学院自主选题研究项目(Z0133)
摘    要:鉴于药品上市前临床试验获得的药品安全性和有效性数据的局限性,开展中药上市后临床再评价是非常必要的.该文讨论中药上市后临床再评价与Ⅳ期临床试验的共同点与区别;根据国内外相关法规,结合专家建议,提出中药上市后临床再评价的基本要求和建议;讨论Ⅳ期临床试验在适应证范围、设计方法、病例入选和排除标准、样本含量等方面的具体要求.

关 键 词:中药  上市后再评价  Ⅳ期临床试验
收稿时间:8/6/2011 12:00:00 AM

Basic requirements on post-marketing clinical re-evaluation of chinese medicine and phase IV clinical trials
XIE Yanming,WANG Yanping,TIAN Feng and WANG Yongyan.Basic requirements on post-marketing clinical re-evaluation of chinese medicine and phase IV clinical trials[J].China Journal of Chinese Materia Medica,2011,36(20):2764-2767.
Authors:XIE Yanming  WANG Yanping  TIAN Feng and WANG Yongyan
Affiliation:Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;Post-doctoral Station of China Academy of Chinese Medical Sciences, Beijing 100700, China;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
Abstract:As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.
Keywords:
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