Sequential design approaches for bioequivalence studies with crossover designs

Pharmaceutical Statistics

Volumn 7, Issue 4, 2008, Pages 245-262

  Potvin, Diane ^a   DiLiberti, Charles E ^b   Hauck, Walter W ^c   Parr, Alan F ^d   Schuirmann, Donald J ^e   Smith, Robert A ^f  

^a INSTITUTE FOR RESEARCH IN IMMUNOLOGY AND CANCER   (Canada)

^b Barr Laboratories Inc   (United States)

^c UNITED STATES PHARMACOPEIA   (United States)

^d GLAXOSMITHKLINE   (United States)

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

^f BRISTOL MYERS SQUIBB PHARMACEUTICAL RESEARCH INSTITUTE   (United States)

Author keywords

Adaptive design; Bioequivalence; Sample size reestimation; Sequential design

Indexed keywords

ARTICLE; BIOEQUIVALENCE; CLINICAL RESEARCH; EFFECT SIZE; MATHEMATICAL ANALYSIS; METHODOLOGY; SEQUENTIAL ANALYSIS; SIMULATION; VALIDATION PROCESS; VARIANCE;

CHEMISTRY, PHARMACEUTICAL; CLINICAL TRIALS AS TOPIC; CROSS-OVER STUDIES; HUMANS; PHARMACEUTICAL PREPARATIONS; RESEARCH DESIGN; THERAPEUTIC EQUIVALENCY;

EID: 57849146499     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.294     Document Type: Article

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