An individual bioequivalence criterion: Regulatory considerations

Statistics in Medicine

Volumn 19, Issue 20, 2000, Pages 2821-2842

  Chen, Mei Ling ^a,b   Patnaik, Rabindra ^a   Hauck, Walter W ^a   Schuirmann, Donald J ^a   Hyslop, Terry ^a   Williams, Roger ^a  

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

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

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDEPRESSANT AGENT; ANTIHYPERTENSIVE AGENT; ANTIINFLAMMATORY AGENT; ANXIOLYTIC AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM CHANNEL BLOCKING AGENT; MONOAMINE OXIDASE INHIBITOR;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BIOSTATISTICS; CLINICAL ARTICLE; CLINICAL TRIAL; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG FORMULATION; FOOD AND DRUG ADMINISTRATION; HUMAN; NORMAL HUMAN; STATISTICAL MODEL; SUSTAINED RELEASE PREPARATION;

AREA UNDER CURVE; GUIDELINES; HUMAN; LEGISLATION, DRUG; MODELS, STATISTICAL; RESEARCH DESIGN; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0034735563     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/1097-0258(20001030)19:20<2821::AID-SIM548>3.0.CO;2-L     Document Type: Article

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