| 质量保证在长期毒性试验原始资料核查中的关注点 |
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| 引用本文： | 宗英,张晓芳,陆国才,袁伯俊.质量保证在长期毒性试验原始资料核查中的关注点[J].中国新药杂志,2011(20). |
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| 作者姓名： | 宗英 张晓芳 陆国才 袁伯俊 |
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| 作者单位： | 第二军医大学药物安全性评价中心; |
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| 摘 要： | 本文论述了质量保证(QA)在长期毒性试验原始资料核查过程中的关注点和主要问题,包括方案、报告和原始记录的一致性、原始资料记录的规范性和准确性、数据核查和资料保存等。分析问题产生的原因,主要归结于GLP意识不强、GLP依从性和SOP的执行力差。对减少问题发生提出了建议和措施,包括加强GLP培训、提高对GLP和SOP的依从性、计算机化仪器系统的运用和专家对GLP单位实施飞行检查等。
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| 关 键 词： | 质量保证 长期毒性试验 原始资料核查 |
Concerns on the source data validation of long-term toxicity test revealed by quality assurance inspection in GLP laboratories |
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| ZONG Ying,ZHANG Xiao-fang,LU Guo-cai,YUAN Bo-jun.Concerns on the source data validation of long-term toxicity test revealed by quality assurance inspection in GLP laboratories[J].Chinese Journal of New Drugs,2011(20). |
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| Authors: | ZONG Ying ZHANG Xiao-fang LU Guo-cai YUAN Bo-jun |
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| Institution: | ZONG Ying,ZHANG Xiao-fang,LU Guo-cai,YUAN Bo-jun(Center for New Drug Evaluation,Second Military Medical University,Shanghai 200433,China) |
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| Abstract: | During the source data validation of long-term toxicity test,the major problems found by quality assurance(QA) were listed and analyzed in this article.The problems include consistency of the protocol,original records and reports,specifications and accuracy of the original data records,data verification and data preservation.The causes may be the bad GLP training,poor GLP compliance and SOP execution.Recommendations are suggested for resolving above problems,which include strength of GLP training,improvemen... |
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| Keywords: | quality assurance(QA) long-term toxicity test source data validation |
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