Evaluation of a scaling approach for the bioequivalence of highly variable drugs

AAPS Journal

Volumn 10, Issue 3, 2008, Pages 450-454

  Haidar, Sam H ^a   Makhlouf, Fairouz ^a   Schuirmann, Donald J ^b   Hyslop, Terry ^a   Davit, Barbara ^a   Conner, Dale ^a   Yu, Lawrence X ^a  

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

^b THOMAS JEFFERSON UNIVERSITY   (United States)

Author keywords

Bioequivalence; Highly variable drugs; Scaled bioequivalence; Simulations

Indexed keywords

DRUG;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG RESEARCH; HUMAN; INTERMETHOD COMPARISON; MAXIMUM PLASMA CONCENTRATION; SIMULATION;

ANALYSIS OF VARIANCE; COMPUTER SIMULATION; CROSS-OVER STUDIES; HUMANS; MODELS, BIOLOGICAL; PHARMACEUTICAL PREPARATIONS; TECHNOLOGY, PHARMACEUTICAL; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 57149091543     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-008-9053-4     Document Type: Article

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