药品评价抽验模式的改进和完善实施方案要点探讨  

Improvement and perfect for the model-marketed drug sampling and testing on the essential of implementation plan for qualitative evaluation

作　　者：张弛[1] 郭志鑫[1] 朱嘉亮[1] 朱炯[1] 姜典才[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11期1964-1968,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:为实现客观、科学、全面反映药品质量的总体水平,保证国家药品评价性抽验结果的准确性,我们初步构建了科学的药品评价模式。方法:新的国家药品抽验方案设计新思路新方法,明确了工作目标。结果与结论:药品评价抽验方案具有可操作性,检验结果更具可比性,质量分析更具科学性,可以对药品质量总体水平作出科学准确的评价评估。Objective： In order to ensure the accuracy of the evaluation sampling result, and reflect the overall drug quality in a scientific and objective manner, we construct a scientific drug evaluation system. Methods：We have design the new National Drug evaluation sampling plan, and definite working objectives. Result and Conclusions： With more practicability, comparability in testing results, scientificity in quality analysis, drug evaluation sampling plan is able to render a more accurate evaluation in improving the overall level of drug quality.

关 键 词：药品抽验模式 药品评价抽验 实施方案 

分 类 号：R917[医药卫生—药物分析学]