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| 仿制原料药研究开发流程及技术要求 | |
| 引用本文： | 刘旭亮,张立颖,臧恒昌. 仿制原料药研究开发流程及技术要求[J]. 齐鲁药事, 2009, 28(12): 746-748 |
| 作者姓名： | 刘旭亮 张立颖 臧恒昌 |
| 作者单位： | 1. 山东大学,山东,济南250012;山东省新华制药股份有限公司,山东,淄博,255005 2. 山东理工大学,山东,淄博255049 3. 山东大学,山东,济南250012 |
| 摘 要： | 本文针对国家食品药品监督管理局对仿制原料药研究开发出台的一些新法规和技术指导原则,研究确定了仿制药研发流程及技术要求,以期对仿制原料药的研发具有一定的指导意义。 |
| 关 键 词： | 药品注册 仿制药 指导原则 |
Process and technical requirement for the development of the active pharmaceutical ingredient (API) generic drugs |
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| LIU Xu-liang,ZHANG Li-ying,ZANG Heng-chang. Process and technical requirement for the development of the active pharmaceutical ingredient (API) generic drugs[J]. qilu pharmaceutical affairs, 2009, 28(12): 746-748 | |
| Authors: | LIU Xu-liang ZHANG Li-ying ZANG Heng-chang |
| Affiliation: | LIU Xu-liang ,ZHANG Li-ying ,ZANG Heng-chang( 1. Shandong University, J i＇ nan 250012 ; 2. Shandong Xinhua Pharmaceutica Share Limited Company,Zibo 255005;3. Shandong University of Technology,Zibo 255049) |
| Abstract: | Based on analyzing new policy and technology guiding principles for drug registration issued by State Food and Drug Administration. The article performs a process and technical requirement for the drug development to guide the development of the API generic drugs. |
| Keywords: | Drug registration generic drug guiding principle |
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