摘要
目的探讨上市药品风险管理的技术模式,为开展我国药品再评价提供技术参考。方法通过分析、总结国外风险管理模式,探索较为实用的评价方式。结果基本掌握了风险管理技术模式。结论通过风险/效益评价,对药品可采取召回、永久撤市、限制使用、修改说明书等措施。
Objective To explore risk management framework in order to provide information for China authority agency. Method Establishing more practical assessing model by referring abroad methods. Results and Conclusion Several measurement including recalls, withdrawals, safety restrictions and labeling changes can be used after risk/ bene?t assessment.
出处
《中国药物警戒》
2004年第1期37-40,共4页
Chinese Journal of Pharmacovigilance
