Reporting of serious and unexpected spontaneous cases of marketed drug: Does the ICH and regulatory authorities need to re-assess the guidelines and recommendations?

被引:0
作者
Agrawal, A. [1 ]
机构
[1] Orchid Healthcare Pvt Ltd, Pharmaceut Med Med Affairs & Pharmacovigilance, Madras, Tamil Nadu, India
关键词
D O I
10.1111/j.1742-1241.2012.02971.x
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
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页码:821 / 821
页数:1
相关论文
共 5 条
[1]   Postmarketing surveillance and adverse drug reactions - Current perspectives and future needs [J].
Brewer, T ;
Colditz, GA .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1999, 281 (09) :824-829
[2]   STIMULATING REPORTING OF ADVERSE DRUG-REACTIONS BY USING A FEE [J].
FEELY, J ;
MORIARTY, S ;
OCONNOR, P .
BRITISH MEDICAL JOURNAL, 1990, 300 (6716) :22-23
[3]   Incidence of adverse drug reactions in hospitalized patients - A meta-analysis of prospective studies [J].
Lazarou, J ;
Pomeranz, BH ;
Corey, PN .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1998, 279 (15) :1200-1205
[4]   Adverse drug reactions in a hospital general medical unit meriting notification to the Committee on Safety of Medicines [J].
Smith, CC ;
Bennett, PM ;
Pearce, HM ;
Harrison, PI ;
Reynolds, DJM ;
Aronson, JK ;
GrahameSmith, DG .
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 1996, 42 (04) :423-429
[5]  
STROM B.L., 1994, PHARMACOEPIDEMIOLOGY