Statistics in Medicine · 1997 · 19 citations · 0 references
PharmacyPharmacokineticsPharmacologyBioavailabilityBioequivalenceNoncompartmental AnalysisBioequivalence AssessmentBioequivalence Study DesignStatistical Analysis Of BioequivalenceEquivalence Interval ApproachFormulation Equivalence AssessmentFormulation InteractionPharmacokinetic Equivalence CriteriaSubject-by-formulation InteractionTolerance Interval Analysis
Evaluation of equivalence of two formulations of a drug typically entails the comparison of average bioavailabilities. Recently, however, authors have become aware that this may be insufficient to assess individual bioequivalence, that is, interchangeability of formulations on an individual basis. This paper outlines a tolerance interval procedure to assess individual bioequivalence based on a model that includes a subject by formulation interaction. We give methods for several higher-order cross-over designs along with examples.