title: Assessment of average, population and individual bioequivalence in two- and four-period crossover studies.
abstract: The aim of bioequivalence studies is to assess the equivalence of two pharmaceutical formulations of the same active drug substance. Currently three types of bioequivalence are distinguished: average, population and individual bioequivalence. Average and population bioequivalence can be assessed in two-period (non-replicated) crossover studies, whereas individual bioequivalence requires three- or four-period replicated studies, with a preference for four-period studies. The PC-program BIOEQV80 is presented for the statistical analysis of average and population bioequivalence from two-period crossover studies. The program BIOEQ2X2 is presented for the statistical analysis of all three types of bioequivalence from four-period replicated crossover studies. The statistical aspects of population and individual bioequivalence are based on a recent Guidance issued by the US Food and Drug Administration.
authors.affiliation: dr.wijnand@planet.nl
authors.forename: Herman P
authors.initials: HP
authors.lastname: Wijnand
mesh_terms: D018592:Cross-Over Studies; D004345:Drug Industry; D013810:Therapeutic Equivalency