| 基于QbD理念的药品质量分析研究新概念 |
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| 引用本文： | 金少鸿,粟晓黎. 基于QbD理念的药品质量分析研究新概念[J]. 药物分析杂志, 2011, 0(10) |
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| 作者姓名： | 金少鸿 粟晓黎 |
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| 作者单位： | 中国食品药品检定研究院; |
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| 摘 要： | 本文阐述质量源于设计理念在药品质量评价分析中的应用基础,结合2010年全国评价性抽验的成效及特点,诠释质量源于设计理念在药品质量评价分析中的应用实践,展望质量源于设计理念在药品抽验工作计划、质量分析、质量再评价研究中的应用前景。
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| 关 键 词： | 药品抽验 质量分析 再评价 质量源于设计 |
A new concept of drug quality surveillance based on quality by design |
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| JIN Shao-hong,SU Xiao-li. A new concept of drug quality surveillance based on quality by design[J]. Chinese Journal of Pharmaceutical Analysis, 2011, 0(10) |
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| Authors: | JIN Shao-hong SU Xiao-li |
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| Affiliation: | JIN Shao-hong,SU Xiao-li(National Institutes for Food and Drug Control,Beijing 100050,China) |
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| Abstract: | The new approach-quality by design(QbD) was introduced into the national drug quality monitoring program in China.The essential concept,the scope and the application of QbD were explained and discussed by using the cases extracted from the 2010 national drug quality monitoring program.It is expected that the further application of QbD in national and local drug quality surveillance programs would greatly improve the output of the program,the ratio of costs and effectiveness.Meanwhile it will also raise the ... |
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| Keywords: | drug quality monitoring program drug quality control revaluation quality by design QbD |
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