Evaluation of parametric and nonparametric two one-sided tests procedures for assessing bioequivalence of average bioavailability.
A simulation study was conducted to compare the levels of significance and power between Schuirmann's and nonparametric two one-sided tests procedures for a 2 x 2 crossover design under different combinations of sample sizes, intrasubject variabilities, and underlying distributions. Empirical results suggest that Schuirmann's two one-sided tests procedure is robust to minor departure from the assumption of normality.
Liu
J P
JP
Berlex Laboratories, Inc., Wayne, New Jersey 07470.
Weng
C S
CS
D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000706:statistics & numerical data*; D010599:Pharmacokinetics; D013810:Therapeutic Equivalency