Comparing generic and innovator drugs: A review of 12 years of bioequivalence data from the United States Food and Drug Administration

Annals of Pharmacotherapy

Volumn 43, Issue 10, 2009, Pages 1583-1597

  Davit, Barbara M ^a   Nwakama, Patrick E ^a   Buehler, Gary J ^a   Conner, Dale P ^a   Haidar, Sam H ^a   Patel, Devvrat T ^a   Yang, Yongsheng ^a   Yu, Lawrence X ^a   Woodcock, Janet ^a  

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

Author keywords

Bioequivalence; Food and Drug Administration; Generic drugs; Pharmacoeconomics

Indexed keywords

ALPHA ADRENERGIC RECEPTOR BLOCKING AGENT; ANTICONVULSIVE AGENT; ANTITHROMBOCYTIC AGENT; CALCIUM CHANNEL BLOCKING AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; GENERIC DRUG; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; IMMUNOSUPPRESSIVE AGENT; METOPROLOL; WARFARIN;

AREA UNDER THE CURVE; BIOEQUIVALENCE; DRUG ABSORPTION; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG RELEASE; FOOD AND DRUG ADMINISTRATION; HUMAN; MAXIMUM PLASMA CONCENTRATION; PRIORITY JOURNAL; RETROSPECTIVE STUDY; REVIEW;

ADMINISTRATION, ORAL; AREA UNDER CURVE; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUGS, GENERIC; HUMANS; PHARMACEUTICAL PREPARATIONS; RETROSPECTIVE STUDIES; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 70449463992     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1M141     Document Type: Review

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