| 药品注册现场核查工作的现状与思考 |
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| 引用本文： | 钟露苗,王铸辉,曾令贵,李超.药品注册现场核查工作的现状与思考[J].中国药事,2012,26(3):211-213,220. |
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| 作者姓名： | 钟露苗 王铸辉 曾令贵 李超 |
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| 作者单位： | 湖南省药品审评认证与不良反应监测中心,长沙,410013 |
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| 摘 要： | 目的 探索药品注册现场核查新的工作模式和方法.方法 通过实践和国内外相关文献调研,总结分析当前药品注册现场核查工作中存在的问题,思考相应对策.结果与结论 针对现阶段药品注册核查工作模式存在的缺陷和核查工作中存在的困难,提出解决思路.为提高核查工作质量与效率提供参考.
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| 关 键 词： | 药品注册现场核查 现状 思考 |
Current Situation and Perspective of On-site Verification for Drug Registration Application |
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| Zhong Lumiao
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Wang Zhuhui
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Zeng Linggui
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Li Chao.Current Situation and Perspective of On-site Verification for Drug Registration Application[J].Chinese Pharmaceutical Affairs,2012,26(3):211-213,220. |
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| Authors: | Zhong Lumiao Wang Zhuhui Zeng Linggui Li Chao |
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| Institution: | (Hunan Center for Drug Evaluation,Certification and ADR Monitoring,Changsha 410013) |
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| Abstract: | Objective To explore appropriate models and methods for on-site verification for drug registration application.Methods Based on practice and related materials published in and outside of China,summarize and analyze the problems of on-site verification in drug registration application,and explore the solutions.Results and Conclusion According to the current defects and difficulties of on-site verification,put forward some clues.It will provide certain reference value to enhance quality and efficiency of On-site Verification. |
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| Keywords: | on-site verification for drug registration application current situation perspective |
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