A Model for Decision Support in Signal Triage

被引:0
|
作者
Bennett Levitan
Chuen L. Yee
Leo Russo
Richard Bayney
Adrian P. Thomas
Stephen L. Klincewicz
机构
[1] Johnson & Johnson Pharmaceutical Services,Pharmaceutical Portfolio & Decision Analysis
[2] Johnson & Johnson Pharmaceutical Research & Development,Medical Pharmacovigilance, Biotechnology/Immunology/Oncology Research & Development
[3] L.L.C.,Benefit Risk Management
[4] Johnson & Johnson Pharmaceutical Research & Development L.L.C.,undefined
来源
Drug Safety | 2008年 / 31卷
关键词
Correlation Plot; Adverse Event Reporting System; Signal Triage; Proportional Reporting Ratio; Suspected Adverse Drug Reaction;
D O I
暂无
中图分类号
学科分类号
摘要
Spontaneous reporting of suspected adverse drug reactions (ADRs) has long been a cornerstone of pharmacovigilance. With the increasingly large volume of ADRs, regulatory agencies, scientific/academic organizations and marketing authorization holders have applied statistical tools to assist in signal detection by identifying disproportionate reporting relationships in spontaneous reporting databases. These tools have generated large numbers of signals defined as drug-ADR reporting associations that meet specified statistical criteria.
引用
收藏
页码:727 / 735
页数:8
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