Sample size determination: extended tables for the multiplicative model and bioequivalence ranges of 0.9 to 1.11 and 0.7 to 1.43.
For the two-period crossover design and a multiplicative model (logarithmic normal distribution) the decision procedure of choice is based on the inclusion of the shortest 90%-confidence interval for the ratio of expected medians for test and reference in the equivalence range. This inclusion rule is equivalent to the two one-sided tests procedure. Sample sizes based on the power of the latter have been given by Diletti et al. [1991] for an equivalence range of 0.8 to 1.25. Corresponding tables for the tighter equivalence range of 0.9 to 1.11 as well as for the wider range of 0.7 to 1.43 are given in this amendment.
Diletti
E
E
Department of Biometry, Byk Gulden Pharmaceuticals, Konstanz, Germany.
Hauschke
D
D
Steinijans
V W
VW
D016001:Confidence Intervals; D006801:Humans; D013223:Statistics as Topic / Q000379:methods*; D013810:Therapeutic Equivalency