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我国药品质量分析研究的方法和策略
引用本文:张弛,朱嘉亮,郭志鑫,姜典才,黄志禄,金少鸿. 我国药品质量分析研究的方法和策略[J]. 中国药事, 2011, 25(1): 63-64
作者姓名:张弛  朱嘉亮  郭志鑫  姜典才  黄志禄  金少鸿
作者单位:国家食品药品监督管理局药品市场监督办公室,北京,100050
摘    要:目的探讨国家药品评价抽验中药品质量分析发展方向和策略。方法对我国药品质量分析的历程和现状进行总结和分析。结果与结论样品的集中检验是药品质量分析的基础。药品质量分析可以相对全面的对药品标准、生产工艺、检验检测方法进行评价,且应与药品质量标准提高等7个方面的工作相结合。

关 键 词:药品质量  分析研究  方法策略

Method and Strategy of the National Drug Quality Study
Zhang Chi,Zhu Jialiang,Guo Zhixin,Jiang Diancai,Huang Zhilu,Jin Shaohong. Method and Strategy of the National Drug Quality Study[J]. Chinese Pharmaceutical Affairs, 2011, 25(1): 63-64
Authors:Zhang Chi  Zhu Jialiang  Guo Zhixin  Jiang Diancai  Huang Zhilu  Jin Shaohong
Affiliation:(Drug Market Compliance Office of State Food and Drug Adminstration,Beijing 100050)
Abstract:Objective To explore development and strategy of drug quality study of national drug sampling and testing for quality evaluation.Methods Summarizing and analyzing the history and current situation of national drug quality study.Results and Conclusion Centralized sample testing is the basis of drug quality study.Drug quality study can general evaluate drug standards,technology and testing methods relatively,which must combine with seven aspects of works such as improvement of drug quality standard.
Keywords:quality  study  method and strategy
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