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作 者:郭志鑫[1] 朱炯[1] 张弛[1] 朱嘉亮[1] 黄志禄[1] 李延敏[2]
机构地区:[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]沈阳药科大学工商管理学院
出 处:《中国药事》2012年第2期155-156,共2页Chinese Pharmaceutical Affairs
摘 要:目的进一步完善我国药品评价抽验模式。方法阐述现行样品确认工作的背景及程序,分析样品确认在国家药品评价抽验工作中的作用。结果归纳出当前国家药品评价抽验模式中样品确认的必要性及存在的问题。结论样品确认工作的开展提高了抽验效能,国家药品评价抽验模式将更加完善。Objective To further consummate the model of marketed drug sampling and testing for quality evaluation in our country.Methods The background and procedure of the current sample confirmation were expounded,and the function of sample confirmation of Marketed Drug Sampling and Testing for Quality Evaluation was analyzed.Results The necessity and problems of sample confirmation of marketed drug sampling and testing for quality evalution were induced in our country.Conclusion Sample confirmation in Marketed Drug Sampling and Testing for Quality Evaluation enhanced the efficiency of the related work.The model of marketed drug sampling and testing for quality evaluation will be consummated in our country.
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