| 中药、天然药物研发过程中立题依据、试验目的与临床试验设计的关系 |
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| 引用本文： | 程龙.中药、天然药物研发过程中立题依据、试验目的与临床试验设计的关系[J].中国临床药理学与治疗学,2007,12(1):11-13. |
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| 作者姓名： | 程龙 |
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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审评一部,北京,100038 |
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| 摘 要： | 新药研发过程中，立题依据、试验目的和试验设计三者关系密切，相互支持，贯穿了新药研发的整个过程。本文就此作一分析，为中药、天然药物研发提供参考。
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| 关 键 词： | 中药 天然药 新药研究 临床试验 |
| 文章编号： | 1009-2501（2007）01-0010-03 |
| 收稿时间： | 2006-08-08 |
| 修稿时间： | 2006-09-20 |
Relationship among base, objective and clinical trial design in development of new traditional Chinese medicine and natural drugs |
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| CHENG Long.Relationship among base, objective and clinical trial design in development of new traditional Chinese medicine and natural drugs[J].Chinese Journal of Clinical Pharmacology and Therapeutics,2007,12(1):11-13. |
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| Authors: | CHENG Long |
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| Abstract: | The relationship was described among base, objective and clinical trial design in the development of new traditional Chinese medicine, and natural drugs in this paper. It will provide a reference for re-searchers to develop the type of drugs. |
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| Keywords: | traditional Chinese medicine natural drugs new drug development clinical trials |
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