The role of databases in drug postmarketing surveillance

Pharmacoepidemiology and Drug Safety

Volumn 10, Issue 5, 2001, Pages 407-410

  Rodriguez, Evelyn M ^a   Staffa, Judy A ^b   Graham, David J ^b  

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

^b Center for Drug Evaluation and Research   (United States)

Author keywords

Adverse drug reactions; Clinical trials, phase IV; Consumer product safety; Pharmacoepidemiology; Pharmacovigilance

Indexed keywords

ANTIANDROGEN; BICALUTAMIDE; CISAPRIDE; FLUTAMIDE; NILUTAMIDE; PIOGLITAZONE; ROSIGLITAZONE; TROGLITAZONE;

ARTICLE; CONTROLLED STUDY; DATA ANALYSIS; DATA BASE; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG USE; EVALUATION; FIBROSING ALVEOLITIS; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION PROCESSING; LIVER FAILURE; LUNG FIBROSIS; MEDICAL DECISION MAKING; METHODOLOGY; PRIORITY JOURNAL; TECHNIQUE; UNITED STATES;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CLINICAL TRIALS; COMMUNITY HEALTH PLANNING; DATABASES; DRUG UTILIZATION REVIEW; HUMANS; PHARMACOEPIDEMIOLOGY; PRODUCT SURVEILLANCE, POSTMARKETING; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0035210598     PISSN: 10538569     EISSN: None     Source Type: Journal    
DOI: 10.1002/pds.615     Document Type: Article

References (6)

1. Physician knowledge, attitudes, and behavior related to reporting adverse drug events
2. Efficacy of reporting systems of adverse reactions to drugs and care
3. Rhode Island physicians reporting of adverse drug reactions
4. Epidemiology of adverse reactions to nonsteroidal antiinflammatory drugs
5. A view from regulatory agencies
6. Comparison of pulmonary toxicity risks with antiandrogens