Novel scaled average bioequivalence limits based on GMR and variability considerations

Pharmaceutical Research

Volumn 21, Issue 10, 2004, Pages 1933-1942

  Karalis, Vangelis ^a   Symillides, Mira ^a   MacHeras, Panos ^a  

^a UNIVERSITY OF ATHENS   (Greece)

Author keywords

bioequivalence; GMR; highly variable drugs; regulatory criteria; scaled bioequivalence limits

Indexed keywords

ARTICLE; BIOEQUIVALENCE; GEOMETRY; MATHEMATICAL ANALYSIS; PRIORITY JOURNAL; RECORDING; SCALE UP; SIMULATION; STATISTICAL ANALYSIS;

ALGORITHMS; ANALYSIS OF VARIANCE; DATA INTERPRETATION, STATISTICAL; HUMANS; SAMPLE SIZE; THERAPEUTIC EQUIVALENCY;

EID: 6344293527     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1023/B:PHAM.0000045249.83899.ae     Document Type: Article

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