Comparison of the reference scaled bioequivalence semi-replicate method with other approaches: Focus on human exposure to drugs

European Journal of Pharmaceutical Sciences

Volumn 38, Issue 1, 2009, Pages 55-63

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

^a UNIVERSITY OF ATHENS   (Greece)

Author keywords

Bioequivalence; Highly variable drugs; Levelling off limits; Replicate design; Scaled average bioequivalence; Scaled bioequivalence limits

Indexed keywords

DRUG;

ARTICLE; BIOEQUIVALENCE; CONSUMER; DRUG EXPOSURE; FOOD AND DRUG ADMINISTRATION; PRIORITY JOURNAL; REFERENCE VALUE; SAMPLE SIZE; SCIENTIST; TREATMENT DURATION;

ALGORITHMS; BIOLOGICAL AVAILABILITY; CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; CROSS-OVER STUDIES; HUMANS; MODELS, BIOLOGICAL; MODELS, STATISTICAL; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; RESEARCH DESIGN; SAMPLE SIZE; THERAPEUTIC EQUIVALENCY;

EID: 67650229575     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2009.05.013     Document Type: Article

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