Part II - BEBAC ⢠Consultancy Services for Bioequivalence
Part II - BEBAC ⢠Consultancy Services for Bioequivalence
Part II - BEBAC ⢠Consultancy Services for Bioequivalence
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6/6 | Statistical Design and Analysis <strong>II</strong>IPotvin et al. (2007)in<strong>for</strong>malife 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 <strong>for</strong> the combined analysis is:fixed: treatment+period+sequence+stage×treatmentrandom: subject(sequence×stage)No poolability criterion; combining is alwaysallowed – even <strong>for</strong> significant differencesbetween Stages.<strong>Bioequivalence</strong> and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201060 • 68