Statistical Evaluation of Bioequivalence Studies - BEBAC ...

Sample Size: Planning• NfG on the Investigation of BA/BE• Problems/solutions• … the error variance associated with the primarycharacteristic to be studied …‣ Since BE must be shown both for AUC and C max, and,‣ if you plan your sample size only for the ‘primary characteristic’(e.g., AUC), in many cases you will fail for thesecondary parameter (e.g., C max), which most likely showshigher variability – your study will be underpowered.‣ Based on the assumption, that CV is identical for test andreference (what if only the reference formulation has highvariability, e.g., *prazoles?).Dissolution Testing, Bioavailability & Bioequivalence | Budapest, 24 May 2007 43