Importance and challenges of studying marketed drugs: What is a phase IV study? common clinical research designs, registries, and self-reporting systems

Journal of Clinical Pharmacology

Volumn 47, Issue 9, 2007, Pages 1074-1086

  Glasser, Stephen P ^a,b   Salas, Maribel ^a   Delzell, Elizabeth ^a  

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^b University of Alabama at Birmingham   (United States)

Author keywords

Clinical trials; Pharmacovigilance pharmacoepidemiology; Phase IV; Postmarketing

Indexed keywords

ALOSETRON; ASTEMIZOLE; BROMFENAC; CERIVASTATIN; CISAPRIDE; DEXFENFLURAMINE; DILTIAZEM; FENFLURAMINE; GREPAFLOXACIN; IBUPROFEN; MIBEFRADIL; NAPROXEN; PARACETAMOL; PHENYLPROPANOLAMINE; RAPACURONIUM BROMIDE; REVIPARIN; ROFECOXIB; TERFENADINE; TROGLITAZONE; VERAPAMIL; WARFARIN; XIMELAGATRAN;

ACUTE HEART INFARCTION; BIOEQUIVALENCE; BRONCHOSPASM; CARDIOTOXICITY; CLINICAL RESEARCH; CLINICAL TRIAL; COLORECTAL ADENOMA; DRUG APPROVAL; DRUG RESEARCH; DRUG SURVEILLANCE PROGRAM; DRUG UTILIZATION; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL SYMPTOM; GASTROINTESTINAL TOXICITY; GOLD STANDARD; HEART ARRHYTHMIA; HUMAN; HYPERTENSION; ISCHEMIC COLITIS; LIVER TOXICITY; METHODOLOGY; NULL HYPOTHESIS; PHARMACOEPIDEMIOLOGY; PHASE 4 CLINICAL TRIAL; POSTMARKETING SURVEILLANCE; REGISTER; REVIEW; RHABDOMYOLYSIS; RHEUMATOID ARTHRITIS; STROKE; UNITED STATES; UNSPECIFIED SIDE EFFECT; VALVULAR HEART DISEASE;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CLINICAL TRIALS, PHASE IV AS TOPIC; DATABASES, FACTUAL; HUMANS; PHARMACEUTICAL PREPARATIONS; PRODUCT SURVEILLANCE, POSTMARKETING; REGISTRIES; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 45849117863     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270007304776     Document Type: Review

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