| 浅谈非临床研究与ADR监测 |
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| 引用本文： | 项晓娟,全红.浅谈非临床研究与ADR监测[J].中国药事,2004,18(8):479-480. |
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| 作者姓名： | 项晓娟 全红 |
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| 作者单位： | 黑龙江中医药大学,哈尔滨,150040 |
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| 摘 要： | "安全性"是药品基本要求之一,对药品安全性的评价则应从药品上市前、后两个阶段进行.药品上市前的安全性评价即非临床研究各项毒性实验以及新药临床试验(Ⅰ,Ⅱ,Ⅲ期),而上市后的安全性评价则属于ADR监测范畴.本文旨在通过对药品非临床研究与ADR监测区别与联系的分析,阐明二者之间的联系,使人们对药品安全性评价加以全面的认识.
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| 关 键 词： | 非临床研究 安全性评价 ADR监测 区别 联系 |
| 文章编号： | 1002-7777(2004)08-0479-02 |
A Preliminary Discussion on Non- Clinical Study and ADR Monitoring |
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| Xiang Xiaojuan and Quan Hong.A Preliminary Discussion on Non- Clinical Study and ADR Monitoring[J].Chinese Pharmaceutical Affairs,2004,18(8):479-480. |
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| Authors: | Xiang Xiaojuan and Quan Hong |
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| Abstract: | To be safety is the elementary requirement for drugs. The evaluation of drug safety should be made from both pre-marketing stage and post-marketing stage. The former stage includes non-clinical trial and clinical trial study while the latter is ADR monitoring stage. This paper analyzed and expressed the relationship and difference between non-clinical trial and ADR monitoring, lead a comprehensive understanding of drug safety evaluation. |
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| Keywords: | Non-clinical study safety evaluation ADR monitoring relationship |
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