| 中药上市后临床再评价研究若干问题思考 |
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| 引用本文： | 何伟,谢雁鸣,王永炎.中药上市后临床再评价研究若干问题思考[J].中国中药杂志,2010,35(12):1641-1643. |
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| 作者姓名： | 何伟 谢雁鸣 王永炎 |
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| 作者单位： | 中国中医科学院,中医临床基础医学研究所,北京,100700 |
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| 基金项目： | 国家"重大新药创制"科技重大专项(2009ZX09502-030) |
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| 摘 要： | 中药上市后再评价是一项复杂的、内容涵盖广泛的、实施难度大的研究工作,而我国上市后再评价起步较晚,从法规制度、技术规范等方面均有待完善。需要就中药上市后临床再评价过程中需注意若干问题,如再评价的法规要求、评价依据、评价对象选择等做初步探讨。
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| 关 键 词： | 中药 上市后临床再评价 |
| 收稿时间： | 3/1/2010 12:00:00 AM |
Thought on several problems of clinical revaluationofpost-marketing herb research |
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| HE Wei,XIE Yanming and WANG Yongyan.Thought on several problems of clinical revaluationofpost-marketing herb research[J].China Journal of Chinese Materia Medica,2010,35(12):1641-1643. |
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| Authors: | HE Wei XIE Yanming and WANG Yongyan |
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| Affiliation: | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700 |
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| Abstract: | The revaluation of post-marketing herb is a complex research work, which concerns widely content and difficult to put it into practice. The starting of our country's revaluation post-marketing herb was comparatively late. It should profect it both in laws and regulations mechanism as well as technological specification. This article is try to focus on some attention problems in revaluation of postmarketing herb process. Such as the laws and regulations demand, the basement and the subject of revaluation of post-marketing herb. |
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| Keywords: | traditional Chinese medicine re-evaluation of clinical postmarketing herbs |
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