希美加群药品风险管理的案例简析

中国药物警戒 ›› 2013, Vol. 10 ›› Issue (2): 84-87.

希美加群药品风险管理的案例简析

郭京,郭剑非

美国俄亥俄州辛辛那提大学药学院,俄亥俄州辛辛那提 45267

收稿日期:2016-03-09 修回日期:2016-03-09 出版日期:2013-02-08 发布日期:2016-03-09

Ximelagatran and Its Risk Management Plan in United States

GUO Jing ,GUO Jian-fei

College of Pharmacy, University of Cincinnati, Ohio Cincinnati 45267, USA

Received:2016-03-09 Revised:2016-03-09 Online:2013-02-08 Published:2016-03-09

摘要/Abstract

摘要： 药品风险管理适用于药品从前体化合物筛选、新药审批、上市后监控以及药品撤出市场的整个过程。通过介绍阿斯利康公司生产的新一代抗凝血药物希美加群（Exanta）从新药审批上市到撤出市场的风险管理相关事件,以期为我国抗凝药物的监测和安全管理工作提供借鉴,从而更好地规范我国的药品市场。

关键词: 希美加群, 药品风险管理, 风险管理计划, 美国食品药品监督管理局

Abstract: The risk management for pharmaceutical products applies toa life cycle ofa new drug development from Investigational New Drug (IND) , New Drug Application (NDA) to post -marketing. It plays a critical role in its withdrawal from the market. In this article we reviewed the risk management events of Ximelagatran(Exanta R) which is a new generation of anti-clotting drug manufactured by AstraZeneca, from its new drug approval to its withdrawal. The experience of Ximelagatran risk management in USA might provide a clue for the future risk manage ment of drug safety in China.

Key words: ximelagatran, drug risk management, risk management plan, FDA

中图分类号:

R954

郭京,郭剑非. 希美加群药品风险管理的案例简析[J]. 中国药物警戒, 2013, 10(2): 84-87.

GUO Jing ,GUO Jian-fei. Ximelagatran and Its Risk Management Plan in United States [J]. Chinese Journal of Pharmacovigilance, 2013, 10(2): 84-87.

参考文献

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