| 模型设计在制剂研发及生产过程质量控制中的应用 |
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| 引用本文： | 陈春,林志强,杨劲.模型设计在制剂研发及生产过程质量控制中的应用[J].药学进展,2011,35(7):289-296. |
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| 作者姓名： | 陈春 林志强 杨劲 |
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| 作者单位： | 1. 中国药科大学,药物代谢与动力学研究中心,江苏,南京,210009
2. 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： | “质量源于设计”概念的提出，将药品的质量控制从生产过程扩展至整个药品生命周期中，而这一概念的核心便是模型设计。介绍模型设计在制剂研发和及生产过程工艺阶段质量控制中的应用情况及模型建立的原理和模型预测结果，并结合笔者所在实验室的模型预测结果，对模型设计在制剂研发生产过程质量控制中的应用进行了评价和展望。
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| 关 键 词： | 质量源于设计 模型设计 质量控制 敏感性分析 制剂研发生产 |
The Application of Model Design in Quality Control of Pharmaceutical Research,Development and Manufacturing |
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| CHEN Chun,LIN Zhi-qiang,YANG Jin.The Application of Model Design in Quality Control of Pharmaceutical Research,Development and Manufacturing[J].Progress in Pharmaceutical Sciences,2011,35(7):289-296. |
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| Authors: | CHEN Chun LIN Zhi-qiang YANG Jin |
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| Institution: | CHEN Chun1,LIN Zhi-qiang2,YANG Jin1(1.Center of Drug Metabolism and Pharmacokinetics,China Pharmaceutical University,Nanjing 210009,China,2.Center for Drug Evaluation,State Food and Drug Administration,Beijing 100038,China) |
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| Abstract: | The concept of Quality by design(QbD) which emphasized quality control during the entire lifecycle of drug product was introduced by ICH.The key point of QbD was model design.The application,mechanism and predicted results of model design in quality control of pharmaceutical research,development and manufacturing were introduced.Meanwhile the predicted results of tramadol hydrochloride sustained-release capsules with physiologically based GI tract absorption model were also considered.Model design was evalu... |
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| Keywords: | Quality by design model design quality control sensitivity analysis pharmaceutical research development and manufacturing |
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