Bioequivalence approaches for highly variable drugs and drug products

Pharmaceutical Research

Volumn 25, Issue 1, 2008, Pages 237-241

  Haidar, Sam H ^a   Davit, Barbara ^a   Chen, Mei Ling ^a   Conner, Dale ^a   Lee, LaiMing ^a   Li, Qian H ^a   Lionberger, Robert ^a   Makhlouf, Fairouz ^a   Patel, Devvrat ^a   Schuirmann, Donald J ^a   Yu, Lawrence X ^a  

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

Author keywords

Bioequivalence; Highly variable drug products; Highly variable drugs; Scaled average bioequivalence; Statistical approach; Study design

Indexed keywords

BIOEQUIVALENCE; DATA ANALYSIS; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; GEOMETRY; NOTE; PRIORITY JOURNAL; REFERENCE VALUE; SIMULATION; STATISTICAL ANALYSIS;

ALGORITHMS; ANIMALS; AREA UNDER CURVE; CHEMISTRY, PHARMACEUTICAL; COMPUTER SIMULATION; HUMANS; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; RESEARCH DESIGN; SOLUBILITY; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 38049184592     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-007-9434-x     Document Type: Note

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