SPONTANEOUS REPORTING - HOW MANY CASES ARE REQUIRED TO TRIGGER A WARNING

被引：20

作者：

TUBERT, P ^{[1
]}

BEGAUD, B ^{[1
]}

HARAMBURU, F ^{[1
]}

PERE, JC ^{[1
]}

机构：

[1] HOP PELLEGRIN,CTR PHARMACOVIGILANCE,F-33076 BORDEAUX,FRANCE

来源：

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY | 1991年 / 32卷 / 04期

关键词：

D O I：

10.1111/j.1365-2125.1991.tb03922.x

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

A statistical method is proposed to aid decisions on the recognition of new adverse drug reactions on the basis of spontaneous reports. The maximal number of associations between drug exposure and event is calculated from an independence test between drug and event, taking into account the expected incidence of that particular event in the general population. An example is given which illustrates the method.

引用

页码：407 / 408

页数：2