“药品安全登记”—它确实有用吗?

中国临床药理学与治疗学 ›› 2009, Vol. 14 ›› Issue (1): 1-4.

• 专论 • 下一篇

“药品安全登记”—它确实有用吗?

谢海棠^1,2, Barton Cobert³, 孙瑞元²

¹中南大学临床药理研究所, 长沙 410078, 湖南;
²皖南医学院弋矶山医院安徽省药物临床评价中心, 芜湖 241001, 安徽;
³BLCMD Associates, President of LLC Westfield, NJ USA

收稿日期:2009-01-31 修回日期:2009-02-05 出版日期:2009-01-26 发布日期:2020-10-27
作者简介:谢海棠, 女, 副研究员, 硕士生导师, 研究方向:中药及临床定理药理学。Tel:0553-5738350 　E-mail:xiehaitang@sina.com
基金资助:
中国博士后基金一等资助项目(20070410314)

Drug safety registries-are they useful?

XIE Hai-tang^1,2, BARTON Cobert³, SUN Rui-yuan²

¹Institute of Clinical Pharmacology, Central South University, Changsha 410078, Hunan, China;
²Anhui Provincial Center for Drug Clinical Evaluation, Yijishan Hospital of Wannan Medical College, Wuhu 241001, Anhui, China;
³Barton Cobert, President BLCMD Associates, LLC Westfield, NJ USA

Received:2009-01-31 Revised:2009-02-05 Online:2009-01-26 Published:2020-10-27
About author:Barton Cobert MD, FACP, FACG, FFPM E-mail:bcobert@blcmd.com www.blcmd.com. Barton Cobert, has had a long, distinguished career in pharmacovigilance, drug safety and risk mangement. He was senior director pharmacovigilance for Schering-Plough Research Institute and held similar positions for Novartis Consumer Health Inc. and Medidata Solutions. He has represented his company and PhRMA at many international meetings and organizations including ICH. Dr. Cobert received his MD from New York University School of Medicine in Manhattan. He haswritten and lectured extensively on pharmacovigilance. He has written three books on drug safety including theManual of Drug Safety and Pharmacovigilance which is used as a textbook in courses on drug safety. Dr. Cobert is president of BLCMD Associated LLC, a drug safety and pharmacovigilance consulting company inWestfield, NJ.

摘要/Abstract

摘要： 药物不良事件(adverse drug events, ADE) 为合格药品的固有属性之一。认识药物的安全性问题, 评价影响ADE 的因素, 并据此制定相应防范措施, 可使用药风险减少到最低限度。笔者参考一些最新资料, 介绍药品安全登记(drug safety registries)这一概念及其相关法规。

关键词: 药物安全性, 登记, 药物不良事件

Abstract: The collection of adverse drug events (ADE) represents one of the inherent attributes of qualified (approved) drugs. The awareness of drug safety problems, the evaluation of the impact of adverse factors, and thus the formulation of corresponding preventive measures will minimize the risk of taking medications. We introduce drug safety registries in referring to some of the latest information on the understanding of the concept of drug safety and related laws and regulations.

Key words: drug safety, registries, adverse drug events

中图分类号:

R969

谢海棠, Barton Cobert, 孙瑞元. “药品安全登记”—它确实有用吗?[J]. 中国临床药理学与治疗学, 2009, 14(1): 1-4.

XIE Hai-tang, BARTON Cobert, SUN Rui-yuan. Drug safety registries-are they useful?[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2009, 14(1): 1-4.

“药品安全登记”—它确实有用吗?

Drug safety registries-are they useful?

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