| 加强我国体外诊断试剂不良事件监测工作 |
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| 引用本文： | 陈亮,张素敏,张承绪.加强我国体外诊断试剂不良事件监测工作[J].中国药物警戒,2008,5(2):80-82. |
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| 作者姓名： | 陈亮 张素敏 张承绪 |
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| 作者单位： | 国家食品药品监督管理局药品评价中心,北京,100045 |
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| 摘 要： | 体外诊断试剂的上市后安全监管工作非常重要。通过分析我国体外诊断试剂监管及不良事件监测的特点与现状,对进一步加强体外诊断试剂的不良事件监测提出了建议。
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| 关 键 词： | 体外诊断试剂 不良事件 监测 |
Strengthening the Supervision of Adverse Event of in-Vitro Diagnostic Reagent |
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| CHEN Liang,ZHANG Su-min,ZHANG Cheng-xu.Strengthening the Supervision of Adverse Event of in-Vitro Diagnostic Reagent[J].Chinese JOurnal of Pharmacovigilance,2008,5(2):80-82. |
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| Authors: | CHEN Liang ZHANG Su-min ZHANG Cheng-xu |
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| Institution: | (Center for Drug Reevaluation,SFDA,Beijing 100045,China) |
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| Abstract: | It is important to pay much attention to the post-market supervision of in-vitro diagnostic reagent. By analyzing its own characteristics and the administration of in vitro-diagnostic reagent, useful suggestions have been brought up to strengthen the supervision of adverse event of in vitro-diagnostic reagent in China. |
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| Keywords: | in-vitro diagnostic reagent adverse event supervision |
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