Evaluation of a limited sampling method used to determine the bioequivalence of highly variable drugs with long half-lives

Biopharmaceutics and Drug Disposition

Volumn 22, Issue 5, 2001, Pages 179-190

  Jackson, Andre J ^a  

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

Author keywords

Bioequivalence; Clearance; Limited sampling approach

Indexed keywords

CHLORPROMAZINE; DANAZOL;

ANALYTIC METHOD; ANALYTICAL ERROR; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL ARTICLE; CONCENTRATION (PARAMETERS); CONSTANTS AND COEFFICIENTS; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG FORMULATION; DRUG HALF LIFE; EVALUATION; FEMALE; HUMAN; MALE; PILOT STUDY; PREDICTION; REGRESSION ANALYSIS; SIMULATION;

AREA UNDER CURVE; HALF-LIFE; HUMANS; SELECTION BIAS; THERAPEUTIC EQUIVALENCY;

EID: 0035210483     PISSN: 01422782     EISSN: None     Source Type: Journal    
DOI: 10.1002/bdd.275     Document Type: Article

References (9)

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5. FDA Guidance for industry - BA and BE studies for orally administered drug products - General considerations - Long Half-life drugs
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9. Some suggestions for measuring predictive performance