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| 风险评估在国家药品评价抽验工作中的应用 | |
| 引用本文： | 郭志鑫,黄志禄,张弛,朱嘉亮,姜雄平,徐万魁,杨悦,李延敏,杨玉奎.风险评估在国家药品评价抽验工作中的应用[J].中国药事,2011,25(8):764-767,775. |
| 作者姓名： | 郭志鑫 黄志禄 张弛 朱嘉亮 姜雄平 徐万魁 杨悦 李延敏 杨玉奎 |
| 作者单位： | 1. 国家食品药品监督管理局药品市场监督办公室,北京,100050 2. 总后卫生部药品仪器检验所 3. 辽宁省食品药品检验所 4. 沈阳药科大学工商管理学院 5. 河南省食品药品监督管理局 |
| 摘 要： | 目的探讨在国家药品评价抽验工作中如何进行风险评估。方法介绍国内外药品风险评估概况及在国家药品评价抽验工作中引入风险评估理念的背景和风险指数的计算原理,对国家评价抽验品种进行风险指数的计算。结果通过在国家药品评价抽验工作中尝试性地进行风险指数的计算,了解了同一品种不同企业的产品质量等级。结论风险评估结果为监管决策提供了一定的技术依据,但仍需要进一步完善。 |
| 关 键 词： | 风险评估 药品评价抽验 风险指数 |
Application of Risk Assessing in State Drug Sampling Analysis for Quality Evaluation |
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| Guo Zhixin,Huang Zhilu,Zhang Chi,Zhu Jialiang,Jiang Xiongping,Xu Wankui,Yang Yue,Li Yanmin , Yang Yukui.Application of Risk Assessing in State Drug Sampling Analysis for Quality Evaluation[J].Chinese Pharmaceutical Affairs,2011,25(8):764-767,775. | |
| Authors: | Guo Zhixin Huang Zhilu Zhang Chi Zhu Jialiang Jiang Xiongping Xu Wankui Yang Yue Li Yanmin Yang Yukui |
| Institution: | Guo Zhixin,Huang Zhilu,Zhang Chi,Zhu Jialiang,Jiang Xiongping1,Xu Wankui2,Yang Yue3,Li Yanmin3 and Yang Yukui4(National Institutes for Food and Drug Control,Beijing 100050,1Institute for Drug and Instrument Control of PLA,2Liaoning Institute for Food and Drug Control,3School of Business Administration,Shenyang Pharmaceutical University,4Henan Food and Drug Administration) |
| Abstract: | Objective Explore the use of risk assessing method in the state drug sampling analysis for quality evaluation.Methods By introducing the general situation of drug risk assessing in domestic and foreign,the background of inducting the risk assessing idea in the area of drug,and the calculation principle of the risk index,calculate the risk index of the sampling and testing products.Results By calculate the risk index in the state drug sampling analysis for quality evaluation,find out the quality level of the... |
| Keywords: | risk assessing drug sampling analysis for quality evaluation risk index |
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