| 关于中药改剂型申请临床方面需关注的问题 |
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| 引用本文： | 王停. 关于中药改剂型申请临床方面需关注的问题[J]. 中国中药杂志, 2012, 37(19): 3001-3002 |
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| 作者姓名： | 王停 |
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| 作者单位： | 国家食品药品监督管理局 药品审评中心,北京,100038 |
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| 摘 要： | 通过分析目前中药改剂型申请临床方面存在的问题,结合现行法规要求,提出研制者在中药改剂型立题目的与依据、临床试验方面需重点关注的问题.
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| 关 键 词： | 中药 改剂型 临床 技术要求 |
| 收稿时间： | 2012-08-21 |
Clinical problems in changing preparation of traditional Chinese medicine |
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| WANG Ting. Clinical problems in changing preparation of traditional Chinese medicine[J]. China Journal of Chinese Materia Medica, 2012, 37(19): 3001-3002 |
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| Authors: | WANG Ting |
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| Affiliation: | Centre for Drug Evalution, State Food and Drug Administration, Beijing 100038, China |
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| Abstract: | The problems in changing preparation of traditional Chinese medicine were analyzed. We explained what the researcher should pay attention to, such as item of purpose and gist, and clinical trail technology requirement, combined with the current regulations. |
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| Keywords: | traditional Chinese medicine change preparation clinic technology requirement |
| 本文献已被 CNKI 万方数据 等数据库收录！ |
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