Statistical Evaluation of Bioequivalence Studies - BEBAC ...

Nonparametrics5. In which cases may a non-parametric statistical modelbe used?However, the true distribution in a pharmacokinetic data set usuallycannot be characterised due to the small sample size, so it is notrecommended to have the analysis strategy depend on a pre-testfor normality. Parametric testing using ANOVA on log-transformeddata should be the rule. Results from non-parametric statisticalmethods or other statistical approaches are nevertheless welcomeas sensitivity analyses. Such analyses can provide reassurancethat conclusions from the experiment are robust against violationsof the assumptions underlying the analysis strategy.Comment: It is well known that the efficiency of e.g., the Wilcoxon-Mann-Whitney test for normal distributed data is 3/π ≈95.5 %; fornot normal distributed data the efficiency is > 100 %!Dissolution Testing, Bioavailability & Bioequivalence | Budapest, 24 May 2007 12