| 生物样品定量分析方法指导原则（草案） |
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| 引用本文： | 钟大放,李高,刘昌孝.生物样品定量分析方法指导原则（草案）[J].药物评价研究,2011(6):409-415. |
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| 作者姓名： | 钟大放 李高 刘昌孝 |
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| 作者单位： | 中国科学院上海药物研究所;华中科技大学同济药学院;天津药物研究院释药技术与药代动力学国家重点实验室 |
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| 摘 要： | 根据目前国际上对生物样品定量分析的相关指导原则,建议《中国药典》修订和扩充现有的的指导原则,以适应新药开发和仿制药开发的需求。内容包括：指导原则适用范围,生物分析方法确证,试验样品分析,配体结合分析,试验报告,以及生物分析相关定义。其中,对基质效应、已测样品再分析、稳定性考察等列出了详细的要求。
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| 关 键 词： | 生物样品分析指导原则 生物分析方法确证 基质效应 已测样品再分析 |
Guidance on Bioanalysis:Method validation and analysis of study samples(Draft) |
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| ZHONG Da-fang,LI Gao,LIU Chang-xiao.Guidance on Bioanalysis:Method validation and analysis of study samples(Draft)[J].Drug Evaluation Research,2011(6):409-415. |
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| Authors: | ZHONG Da-fang LI Gao LIU Chang-xiao |
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| Institution: | 1. Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China 2. Tongji College of Pharmacy, Center China University of Science and Technology, Wuhan 430030, China 3. State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China |
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| Abstract: | This is the draft version for the Guidance on Bioanalysis in China Pharmacopoeia, 2015 Edition. The recommendations are based on the current international guidelines and for adepting the requirements to the development of new drugs and generic drugs. It is composed of scope of the guidance, method validation, analysis of study samples, incurred samples reanalysis, ligand binding assays, reports, and definitions. Detailed requirements for matrix effect, incurred samples reanalysis, and stability investigation are introduced. |
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| Keywords: | guidance on bioanalysis method validation matrix effect incurred samples reanalysis |
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