Risk management plans as a tool for proactive pharmacovigilance: A cohort study of newly approved drugs in Europe

Clinical Pharmacology and Therapeutics

Volumn 96, Issue 6, 2014, Pages 723-731

  Vermeer, N S ^a,b   Duijnhoven, R G ^a,b   Straus, S M J M ^b,c   Mantel Teeuwisse, A K ^a   Arlett, P R ^d   Egberts, A ^a,e   Leufkens, H G M ^a,b   de Bruin, M L ^a,b  

^a UTRECHT UNIVERSITY   (Netherlands)

^b Erasmus Medical Center ^*  (Netherlands)

^c ERASMUS MEDICAL CENTER   (Netherlands)

^d EUROPEAN MEDICINES AGENCY   (United Kingdom)

^e UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

AGENTS AFFECTING METABOLISM; ANTIINFECTIVE AGENT; BIOLOGICAL PRODUCT; CARDIOVASCULAR AGENT; NEW DRUG; RIMONABANT; SITAXSENTAN;

ADVERSE DRUG REACTION; ARTICLE; DRUG APPROVAL; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPE; HUMAN; KNOWLEDGE; PRIORITY JOURNAL; RISK ASSESSMENT; RISK FACTOR; RISK MANAGEMENT; RISK MANAGEMENT PLAN; UNCERTAINTY; COHORT ANALYSIS;

COHORT STUDIES; DRUG APPROVAL; EUROPE; HUMANS; PHARMACOVIGILANCE; RISK MANAGEMENT;

EID: 85027923812     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2014.184     Document Type: Article

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