Choice of student's t- or Wilcoxon-based confidence intervals for assessment of average bioequivalence.
An open question in the analysis of average bioequivalence is whether the nonparametric (Wilcoxon) or parametric (t) approaches to two one-sided tests is preferable. Previous work has made particular distributional assumptions as to the distribution of AUC and C(max). Instead, we simulate data according to a pharmacokinetic model for an immediate-release formulation. We find that both approaches have estimated level consistent with the nominal 5%. The only concern is a possible anticonservativeness of the parametric approach for C(max). Further, the nonparametric approach is consistently less powerful than the parametric for the cases studied.
Hauck
W W
WW
Biostatistics Section, Division of Clinical Pharmacology, Thomas Jefferson University, Philadelphia, Pennsylvania 19107, USA.
Hauschke
D
D
Diletti
E
E
Bois
F Y
FY
Steinijans
V W
VW
Anderson
S
S
D019540:Area Under Curve; D003198:Computer Simulation; D016001:Confidence Intervals; D018592:Cross-Over Studies; D006801:Humans; D008954:Models, Biological; D015233:Models, Statistical; D016011:Normal Distribution; D018709:Statistics, Nonparametric; D013810:Therapeutic Equivalency