摘要
目的了解欧盟药品抽验的模式和经验,对我国的评价抽验提供参考和借鉴。方法介绍了针对欧盟集中审评程序批准上市药品的抽验中,以风险为基础的抽验品种选择方法 ,对其中的风险水平量化模型以及专家意见法给予分析。结果与结论对我国的药品评价抽验具有一定的参考价值。
Objective To understand the models and experience of drug sampling and testing in the EU,to provide some references for our country.Methods This article elaborated on the risk-based selection approach for testing samples of EMEA centrally authorised products,with which quantitative model of risk levels was provided and expert opinions were analyzed.Results and Conclusion Providing some references to drug sampling and testing in China.
出处
《中国药事》
CAS
2010年第6期617-618,共2页
Chinese Pharmaceutical Affairs
