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中国临床药理学与治疗学 ›› 2007, Vol. 12 ›› Issue (11): 1201-1204.

• 专论 •    下一篇

药物单一不良事件因果关系的鉴别和评价

杨进波   

  1. 国家食品药品监督管理局药品审评中心, 北京100038
  • 收稿日期:2007-10-05 修回日期:2007-10-30 发布日期:2020-11-04
  • 作者简介:杨进波, 男, 副主任药师, 主要从事药品技术审评工作。Tel:010-68585566-456 E-mail: yangjb@cde.org.cn

To identify and evaluate causal relationship between drug and single adverse event

YANG Jin-bo   

  1. Center for Drug Evaluation, State Food and Drug Administration, Beijing 100038,China
  • Received:2007-10-05 Revised:2007-10-30 Published:2020-11-04

摘要: 分析药物不良事件与用药是否相关是安全性评价的重要内容。参考相关文献, 本文介绍了以病例为基础药物单一不良事件的鉴别和评价方法以及目前依然面临的挑战。

关键词: 药物, 不良事件, 鉴别, 评价

Abstract: It is very important in safety evaluation to determining causal relationship between drugs and adverse events. Supported by the available literatures, the purpose of this review is to introduce some methods to identify and assess simple adverse event, and some challenges remain need to face to.

Key words: drug, adverse event, identify, evaluate