药品评价抽验模式的改进和完善——对药品质量状况分析方法的初探  

Improvement and perfect for the model-marketed drug sampling and testing for quality evaluation——preliminary discussion on the drug quality study

作　　者：朱嘉亮[1] 姜典才[1] 张弛[1] 郭志鑫[1] 朱炯[1] 黄志禄[1] 任春[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]辽宁省食品药品检验所,沈阳110023

出　　处：《药物分析杂志》2009年第10期1765-1767,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：药品抽验质量分析能促进药品质量标准的提高,可以对药品质量总体水平做出较为科学的评估。药品质量分析探索性工作已经开展并初见成效,证明了质量分析的重要作用,体现了真正意义的技术监督。本文对在新的药品监管形势下药品评价抽验的目的、要求及作用进行了简要介绍,重点对如何在新的药品评价抽验模式下搞好药品质量分析工作提出了思路和建议。The application of quality study can promote the improvement of drug quality standard, and evaluate the overall drug quality in a scientific manner. The work of model - marketed drug sampling and testing for quality evaluation has achieved initial success, the outcome got in previous work demonstrates the importance and role of marketed drug researchable quality analysis, and reflects technological support in effect. The paper briefly describes the purpose, requirements and role of a new model - marketed drug sampling and testing for quality evaluation, and the suggestion and the way of doing marketed drug researchable quality study in this model, under the new environment of drug market administration.

关 键 词：药品抽验模式 药品评价抽验 质量分析 

分 类 号：R917[医药卫生—药物分析学]