国外药品效益风险评价研究进展

中国药物警戒 ›› 2013, Vol. 10 ›› Issue (8): 473-477.

国外药品效益风险评价研究进展

卢玉美,张明慧,武志昂^*

沈阳药科大学工商管理学院,辽宁沈阳 110016

收稿日期:2013-03-12 修回日期:2016-03-09 出版日期:2013-08-08 发布日期:2016-03-09
通讯作者: 武志昂,男,教授,博士生导师。E-mail:wuerla501@126.com
作者简介:卢玉美,女,在读硕士,药品政策法规。

Overview of Drug Benefit-Risk Assessment Research Progress

LU Yu –mei, ZHANG Ming –hui, WU Zhi -ang^*

Business School of Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China

Received:2013-03-12 Revised:2016-03-09 Online:2013-08-08 Published:2016-03-09

摘要/Abstract

摘要： 药品的效益风险评价是保证药品安全性的重要手段,因此建立科学、综合、统一的评价方法和框架尤为重要。本文从监管机构、行业组织以及企业3 个角度,分别阐述国外药品效益风险评价的热点问题与研究进展。同时结合我国研究现状,对国内药品效益风险评价提出建议。

关键词: 药品, 效益, 风险, 评价

Abstract: Benefit-risk assessment is an important means of ensuring drug safety, so it is particularly important to establish scientific, comprehensive and unified evaluation method and framework. In order to understand the foreign research situation of drug benefit-risk assessment, this article describes the hot topics and research progress among regulatory agencies, industry organizations, as well as enterprise, and further summerises the challenges and prospects of current research areas. Moreover, based on the present situation of our country, the article provides reference for domestic drugs benefit-risk assessment.

Key words: drugs, benefit, risk, assessment

中图分类号:

R951

卢玉美,张明慧,武志昂. 国外药品效益风险评价研究进展[J]. 中国药物警戒, 2013, 10(8): 473-477.

LU Yu –mei, ZHANG Ming –hui, WU Zhi -ang . Overview of Drug Benefit-Risk Assessment Research Progress [J]. Chinese Journal of Pharmacovigilance, 2013, 10(8): 473-477.

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