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| 药品质量标准制订的QbD理念初探 | |
| 引用本文： | 陈桂良,王麟达,李慧义,陶巧凤.药品质量标准制订的QbD理念初探[J].上海医药,2012,33(9):46-49. |
| 作者姓名： | 陈桂良 王麟达 李慧义 陶巧凤 |
| 作者单位： | 1. 上海市食品药品检验所,上海,201203 2. 国家药典委员会,北京,200061 3. 浙江省食品药品检验所,杭州,324201 |
| 摘 要： | 本文介绍了基于质量源于设计(QbD)理念的药品质量标准制订过程,通过获取有用的与药品质量有关的信息和药品本身蕴藏着的丰富知识,采用科学的风险评估、寻找关键的质量属性、进行合理的空间设计,制订可行的达到全面认识的质量标准.为我国药品质量标准的制订提供参考. |
| 关 键 词： | QbD 药品质量标准 设计空间 操作空间 |
An introduction of QbD principles in the development of drug quality standard |
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| CHEN Gui-liang , WANG Lin-da , LI Hui-yi , TAO Qiao-feng.An introduction of QbD principles in the development of drug quality standard[J].Shanghai Medical & Pharmaceutical Journal,2012,33(9):46-49. | |
| Authors: | CHEN Gui-liang WANG Lin-da LI Hui-yi TAO Qiao-feng |
| Institution: | 1.Shanghai Institute for Food and Drug Control,Shanghai,201203;2.Chinese Pharmacopoeia Convention,Beijing,100061;3.Zhejiang Institute for Food and Drug Control,Hangzhou,324201) |
| Abstract: | The development of drug quality standard is introduced based on the principles of Quality by Design(QbD).A comprehensive understanding of quality standards can be established using the useful information related with drug quality and the rich knowledge contained in the drug,adopting scientific risk assessment,finding the critical quality attributes and employing the reasonable space design.The process can be a reference for the development of our drug quality standards. |
| Keywords: | QbD drug quality standards design space operating space |
| 本文献已被 CNKI 万方数据 等数据库收录！ | |