| 创新药物研发中的CMC阶段性研究 |
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| 引用本文： | 何伍,潘卫三. 创新药物研发中的CMC阶段性研究[J]. 中国新药杂志, 2010, 0(2) |
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| 作者姓名： | 何伍 潘卫三 |
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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;沈阳药科大学; |
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| 摘 要： | CMC阶段的研究是药物研发的重要方面,但是创新药物和仿制药物的CMC阶段研究有一定的区别,通过对两者CMC研究区别的分析,说明了创新药物研发中CMC进行阶段性要求的必要性,阐述了目前创新药物CMC研究存在的主要问题,明确了药物研发各阶段CMC研究应关注的重点。
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| 关 键 词： | 创新药物 CMC阶段研究 研发 |
CMC research in drug research and development |
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| HE Wu,PAN Wei-san. CMC research in drug research and development[J]. Chinese Journal of New Drugs, 2010, 0(2) |
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| Authors: | HE Wu PAN Wei-san |
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| Affiliation: | HE Wu1,PAN Wei-san2 (1 Center for Drug Evaluation,State Food , Drug Administration,Beijing 100038,China,2 Shenyang Pharmaceutical University,Shenyang 110016,China) |
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| Abstract: | CMC research is a very important aspect in drug research and development.In this article,we analyzed the difference in CMC research between new drug and generic drugs,and explained the necessity of different requirements of CMC research in new drugs' development period,and illuminated the main problems and emphases in new drug CMC research. |
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| Keywords: | new drug CMC research research and development |
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