In vivo bioequivalence and in vitro similarity factor (f2) for dissolution profile comparisons of extended release formulations: How and when do they match?

Pharmaceutical Research

Volumn 28, Issue 5, 2011, Pages 1144-1156

  Duan, John Z ^a   Riviere, Kareen ^a   Marroum, Patrick ^a  

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

Author keywords

bioequivalence; dissolution; f2 similarity factor; IVIVC; modeling and simulation

Indexed keywords

DRUG;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; DRUG SOLUBILITY; EXTENDED RELEASE FORMULATION; IN VITRO STUDY; IN VIVO STUDY; MAXIMUM PLASMA CONCENTRATION; PHARMACOLOGICAL PARAMETERS; PRIORITY JOURNAL; SIMILARITY FACTOR; SIMULATION; STATISTICAL MODEL; TIME TO MAXIMUM PLASMA CONCENTRATION;

ANIMALS; AREA UNDER CURVE; COMPUTER SIMULATION; DELAYED-ACTION PREPARATIONS; HUMANS; MODELS, BIOLOGICAL; MODELS, CHEMICAL; PHARMACEUTICAL PREPARATIONS; SOLUBILITY; THERAPEUTIC EQUIVALENCY;

EID: 79955593881     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-011-0377-x     Document Type: Article

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