关于对儿童药物警戒之技术发展方向的思考

中国药物警戒 ›› 2011, Vol. 8 ›› Issue (4): 220-224.

关于对儿童药物警戒之技术发展方向的思考

沈璐, 杜晓曦

国家食品药品监督管理局药品评价中心,北京 100045

收稿日期:2015-08-27 修回日期:2015-08-27 出版日期:2011-04-10 发布日期:2015-08-27
通讯作者: 杜晓曦,女,主任药师,中药学。E-mail:duxiaoxi@cdr.gov.cn
作者简介:沈璐,女,主管药师,药事法规。

Discussion on the Technical Development of Pediatric Pharmacovigilance

SHEN Lu, DU Xiao-xi

Center for Drug Reevaluation, SFDA, Beijing 100045, China

Received:2015-08-27 Revised:2015-08-27 Online:2011-04-10 Published:2015-08-27

摘要/Abstract

摘要： 在药物警戒理论和实践的基础上,结合儿童及儿童用药的特殊性,借鉴国外经验,通过对儿童药物警戒的特点、在儿童药物警戒中相关方的角色与职责、儿童用药的上市前药物警戒、儿童用药的上市后药物警戒等方面的讨论,试图构建儿童药物警戒的初步框架,为我国实行针对儿童等特殊人群的药物警戒工作提供参考。

关键词: 儿童用药, 药物警戒, 发展

Abstract: This article is based on the theory and the practice of pharmacovigilance(PV), and combined with the essential character of pediatric medication. The writer discusses on the special characteristics of pediatric PV, the role and responsibilities of different stakeholders, PV before authorization of a pediatric indication and PV for products on the market. We try to establish the frame of pediatric PV, and hope this pilot helpful for the practice of PV on special population like children.

Key words: medicines used by the pediatric population, pharmacovigilance, development

中图分类号:

R954

沈璐, 杜晓曦. 关于对儿童药物警戒之技术发展方向的思考[J]. 中国药物警戒, 2011, 8(4): 220-224.

SHEN Lu, DU Xiao-xi. Discussion on the Technical Development of Pediatric Pharmacovigilance[J]. Chinese Journal of Pharmacovigilance, 2011, 8(4): 220-224.

参考文献

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