Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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6/6 | Statistical Design and Analysis IIIPotvin et al. (2007)informalife sciencesTechnical Aspects (cont’d)If the study is stopped after Stage 1,the (conventional) statistical model is:fixed: treatment+period+sequencerandom: subject(sequence)If the study continues to Stage 2,the model for the combined analysis is:fixed: treatment+period+sequence+stage×treatmentrandom: subject(sequence×stage)No poolability criterion; combining is alwaysallowed – even for significant differencesbetween Stages.Bioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201060 • 68
6/6 | Statistical Design and Analysis IIIPotvin et al. (2007)informalife sciencesAdvantageCurrently the only validated procedure for BE!DrawbacksNot validated for a correction of effect size (PE)observed in Stage 1 (must continue with theone used in sample size planing).No stop criterion (EMA GL on BE?)Not validated for any other design than theconventional 2×2 crossover (no higher ordercrossovers, no replicate designs).Bioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201061 • 68
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Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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Part II - BEBAC â¢ Consultancy Services for Bioequivalence