Pharmacovigilance in Perspective

被引：0
|
作者：
Ronald H. B. Meyboom
Antoine C. G. Egberts
Frank W. J. Gribnau
Yechiel A. Hekster
机构：
[1] Netherlands Pharmacovigilance Foundation LAREB,Department of Pharmacoepidemiology and Pharmacotherapy
[2] Utrecht University,Department of Clinical Pharmacology
[3] TweeSteden Ziekenhuis,Department of Clinical Pharmacy
[4] Nijmegen University Hospital St Radboud,undefined
[5] Nijmegen University Hospital St Radboud,undefined
[6] The Uppsala Monitoring Centre,undefined
来源：
Drug Safety | 1999年 / 21卷
关键词：
Adis International Limited; Adverse Drug Reaction; Spontaneous Reporting; Drug Regulation; Pharmacovigilance Centre;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
Pharmacovigilance is more than spontaneous reporting alone, and the evaluation of marketed medicines is more than just pharmacovigilance. The positioning of a drug usually takes place during the years following introduction, when worldwide experience has accumulated. Originally a modest appendix of drug regulation, pharmacovigilance has become a major activity. The provision of the information needed for the evaluation of the benefits and risks of drugs is in the first place a scientific challenge. In addition, there are important ethical, logistical, legal, financial and commercial constraints. Good pharmacovigilance practice needs to be developed to ensure that data are collected and used in the right way and for the right purpose.
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页码：429 / 447
页数：18
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