Presentation of the intrasubject coefficient of variation for sample size planning in bioequivalence studies.
Bioequivalence studies are generally performed as crossover studies and, therefore, information on the intrasubject coefficient of variation is needed for sample size planning. Unfortunately, this information is usually not presented in publications on bioequivalence studies, and only the pooled inter- and intrasubject coefficient of variation for either test or reference formulation is reported. Thus, the essential information for sample size planning of future studies is not made available to other researchers. In order to overcome such shortcomings, the presentation of results from bioequivalence studies should routinely include the intrasubject coefficient of variation. For the relevant coefficients of variation, theoretical background together with modes of calculation and presentation are given in this communication with particular emphasis on the multiplicative model.
Hauschke
D
D
Department of Biometry, Byk Gulden Pharmaceuticals, Konstanz, Germany.
Steinijans
W V
WV
Diletti
E
E
Schall
R
R
Luus
H G
HG
Elze
M
M
Blume
H
H
D006801:Humans; D008962:Models, Theoretical; D018401:Sample Size; D013810:Therapeutic Equivalency