| 新法规下仿制药研发中几个关键问题的思考 |
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| 引用本文： | 张哲峰.新法规下仿制药研发中几个关键问题的思考[J].中国药事,2010,24(9):840-844. |
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| 作者姓名： | 张哲峰 |
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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： | 目的提出对仿制药研发思路和策略相关问题的认识和建议,以期在药物研发中得到相应关注和改进,提高我国药物研发的水平和质量。方法根据新版《药品注册管理办法》对仿制药注册申请提出的技术要求,从药物研发规律、药品质量及其形成过程和控制要素出发,在仿制药研发的立题思考、研发理念、生产工艺与质量相关性等方面,阐述仿制药的研发思路和质量控制要素。结果与结论＂质量源于设计、过程决定质量、检验揭示品质＂将是药品研发过程中科学的世界观和方法论,＂桥接的研究思路、对比的研究策略＂是仿制药研发的基本思想,要充分体现在药物研发的科学实践中。
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| 关 键 词： | 仿制药 质量形成与控制 对比研究 桥接 |
Considerations on Several Key Issues during the Research and Development of Generic Drugs under the New Regulations |
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| Zhang Zhefeng.Considerations on Several Key Issues during the Research and Development of Generic Drugs under the New Regulations[J].Chinese Pharmaceutical Affairs,2010,24(9):840-844. |
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| Authors: | Zhang Zhefeng |
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| Affiliation: | Zhang Zhefeng(Center for Drug Evaluation,State Food and Drug Administration,Beijing 100038) |
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| Abstract: | Objective To propose knowledge and recommendations for issues related to R&D ideas and strategies for generic drugs to obtain corresponding concerns and improvements during drug R&D,thus to improve the level and quality of drug R&D in our country. Methods According to the technical requirements on generic drug applications prescribed in the new edition of Provisions for Drug Registration,describe R&D ideas and quality control elements of generic drugs with respect to considerations on rationale for study,R&... |
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| Keywords: | generic drug quality formation and control comparative study bridging |
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