On the leveling-off properties of the new bioequivalence limits for highly variable drugs of the EMA guideline

European Journal of Pharmaceutical Sciences

Volumn 44, Issue 4, 2011, Pages 497-505

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

^a UNIVERSITY OF ATHENS   (Greece)

Author keywords

Bioequivalence; European Medicines Agency guideline; Highly variable drugs; Leveling off limits; Scaled limits; Simulated studies

Indexed keywords

ACCURACY; ARTICLE; BIOEQUIVALENCE; DRUG ACTIVITY; GEOMETRIC MEAN RATIO; LEVELING-OFF PROPERTY; MAXIMUM PLASMA CONCENTRATION; NATIONAL HEALTH ORGANIZATION; PHARMACOLOGICAL PARAMETERS; PRACTICE GUIDELINE; PRIORITY JOURNAL; SAMPLE SIZE; SIMULATION;

ALGORITHMS; CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; CROSS-OVER STUDIES; DRUG APPROVAL; EPIDEMIOLOGIC RESEARCH DESIGN; EUROPE; GUIDELINES AS TOPIC; HUMANS; MODELS, BIOLOGICAL; PHARMACOKINETICS; SAMPLE SIZE; THERAPEUTIC EQUIVALENCY;

EID: 80455143769     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2011.09.008     Document Type: Article

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