The role of databases in drug postmarketing surveillance
The role of databases in drug postmarketing surveillance
复制标题
DOI：
10.1002/pds.615
复制
发表时间：
2001-08-01
影响因子：
2.6
通讯作者：
Graham, DJ
中科院分区：
文献类型：
--
作者：
Rodriguez, EM;Staffa, JA;Graham, DJ
本文介绍了美国食品药品监督管理局（FDA）用于药品上市后监测的数据库的作用。首先，我们描述不良事件报告系统（AERS），世界上最大的不良事件报告数据库。接下来，我们将解释我们用于将这些不良事件报告组装成病例系列并对其进行分析的方法，以及采用药物使用数据库构建药物安全性问题评价报告率的技术。最后，我们讨论了FDA通过其合作协议计划访问的数据库的使用，以进行高优先级的研究，以支持监管决策。出版社：John Wiley & Sons，Ltd.
This paper describes the role of databases used for postmarketing surveillance of drugs at the United States Food and Drug Administration (FDA). First we describe the Adverse Event Reporting System (AERS), the largest database of adverse event reports in the world. Next, we explain the methods we have used for assembling these adverse event reports into a case series and analysing them, as well as techniques for employing drug use databases to construct reporting rates in the evaluation of drug safety issues. Finally, we discuss the FDA's use of the databases it accesses through its Cooperative Agreement Program to conduct high priority studies to support regulatory decision-making. Published in 2001 by John Wiley & Sons, Ltd.