Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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6/6 | Statistical Design and Analysis IIIEUNfG on the Investigation of BA/BE (2001)The number of subjects required is determined by the error variance associated with the primarycharacteristic to be studied as estimated from a pilot experiment, previous studies, or published data, the significance level desired, the expected deviation (∆) from the reference productcompatible with BE and, the required power.informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 20104 • 68
6/6 | Statistical Design and Analysis IIIEUNfG on the Investigation of BA/BE (2001)Problems/solutions… the error variance associated with theprimary characteristic 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., some formulations of PPIs?).informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 20105 • 68
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Part II - BEBAC â¢ Consultancy Services for Bioequivalence