Informatic tools and approaches in postmarketing pharmacovigilance used by FDA

AAPS Journal

Volumn 10, Issue 1, 2008, Pages 35-41

  Weaver, Joyce ^a   Willy, Mary ^a   Avigan, Mark ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Postmarketing product surveillance

Indexed keywords

ANTIDEPRESSANT AGENT; ANTIINFECTIVE AGENT; BETA1A INTERFERON; CELECOXIB; IMMUNOSUPPRESSIVE AGENT; NATALIZUMAB; PLACEBO; ROFECOXIB; SALMETEROL XINAFOATE; SEROTONIN UPTAKE INHIBITOR; TERFENADINE; VALDECOXIB;

ASTHMA; CASE CONTROL STUDY; CLINICAL TRIAL; COHORT ANALYSIS; CROHN DISEASE; DATA BASE; DOSE RESPONSE; DRUG APPROVAL; DRUG FATALITY; DRUG INDICATION; DRUG INFORMATION; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EMERGENCY WARD; FOOD AND DRUG ADMINISTRATION; FUNDING; HEALTH CARE ORGANIZATION; HEALTH CARE SYSTEM; HEALTH PROGRAM; HEART ARRHYTHMIA; HUMAN; INFORMATION PROCESSING; INFORMATION SERVICE; LIVER INJURY; MEDICAL INFORMATION SYSTEM; MULTIPLE SCLEROSIS; PHARMACOEPIDEMIOLOGY; PRESCRIPTION; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; QT PROLONGATION; REVIEW; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; STEVENS JOHNSON SYNDROME; SUICIDAL BEHAVIOR; SUICIDAL IDEATION; SYNCOPE; THROMBOEMBOLISM; TORSADE DES POINTES; TOXIC EPIDERMAL NECROLYSIS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ANIMALS; DRUGS, INVESTIGATIONAL; HUMANS; MEDICAL INFORMATICS; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 51249113660     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-007-9004-5     Document Type: Review

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