| 中药复方新药立题依据的临床问题探讨 |
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| 引用本文： | 郭洁,董宇,唐健元. 中药复方新药立题依据的临床问题探讨[J]. 中国中药杂志, 2017, 42(5): 844-847 |
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| 作者姓名： | 郭洁 董宇 唐健元 |
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| 作者单位： | 天津中医药大学第二附属医院, 天津 300150,中国中医科学院 广安门医院, 北京 100053,国家食品药品监督管理总局 药品审评中心, 北京 100038 |
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| 基金项目： | 国家中医药管理局中医药行业专项（201207009） |
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| 摘 要： | 针对医药行业内对中药复方新药申请临床研究立题依据认识不足的情况,从临床技术评价角度,对近年来中药复方新药研发的现状和路径进行了回顾分析,并对临床评价中存在的相关问题,从组方合理性、人用经验和临床研究方案角度探讨分析,提出了中药复方新药临床技术评价存在的困难与对策,以期共同提高中药新药临床研究的水平。
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| 关 键 词： | 立题依据 中药复方 临床审评 |
| 收稿时间： | 2017-02-10 |
Discussion on clinical problems about bases of new drug of traditional Chinese medicine development |
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| GUO Jie,DONG Yu and TANG Jian-yuan. Discussion on clinical problems about bases of new drug of traditional Chinese medicine development[J]. China Journal of Chinese Materia Medica, 2017, 42(5): 844-847 |
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| Authors: | GUO Jie DONG Yu TANG Jian-yuan |
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| Affiliation: | The Second Hospital Affiliated to Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China,Guang''anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China and Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China |
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| Abstract: | In view of the industry lacking of sufficient analyses on the bases of project establishment about the new drugs of traditional Chinese medicine(TCM) during their applying for the clinical research, from the perspective of clinical evaluation, this paper reviewed and analyzed the present situation and development paths of new drugs of TCM in recent years. Through the analyses of the rationality of formulations, human use experiences and clinical studies, the paper puts forward the countermeasures to solve these difficulties during the technical evaluation of new drugs of TCM in order to improve the new drugs'' clinical research. |
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