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王海南.中药新药临床试验的特点和难点[J].中国中西医结合杂志,2007,(7):650-652
中药新药临床试验的特点和难点
Characteristics and Difficulties in Clinical Trials of New Traditional Chinese Drugs
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DOI:
中文关键词:  中药新药  临床试验  特点  难点
英文关键词:new traditional Chinese drug  clinical trial  characteristics  difficulties
基金项目:
作者单位
王海南 国家食品药品监督管理局药品审评中心 (北京100038 
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全文下载次数: 5
中文摘要:
      中药新药的疗效是其研发的出发点和归宿点,而临床试验则为中药新药疗效的判定提供了一个很好的平台。本文通过中成药与中药汤剂的差异比较明晰了中成药的特点,并结合中药新药研发现状及相关研究进展对中药新药临床试验的特点、难点进行了探讨。
英文摘要:
      Therapeutic efficacy is the point of starting and ending for research and developing of new traditional Chinese drugs, and clinical trials could provide a good platform for its efficacy evaluation. The characteristics of Chinese patent medicine is clarified in this paper by comparing its difference from Chinese herbal decoction, and the characteristics and difficulties in clinical trials for developing Chinese new drugs were also probed in referrence to the present situation and progress of the concerning topics.
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