Part III - BEBAC â¢ Consultancy Services for Bioequivalence

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Taking a Biostatistical Approach to Designing a BioequivalenceB Study: Ensuring Success through Effective Planning (3/3) Open Issues Fixed and random effects, ANOVA… cont’d Answer: There is an inherent risk if the applicant uses PROC mix and does not remove the missing data prior to evaluation as there will be a fitting of data and this will lead to a difference between PROC Mix and other SAS models. Medicines agencies will accept the use of PROC Mix or other PROC as long as the handling of missing data is pre-defined. Its use will not result in arbitration. My recommendation: Use a mixed model for replicate design studies. Bioequivalence & Bioavailability Studies | Munich, 252 October 2010 161 • 162
Taking a Biostatistical Approach to Designing a BioequivalenceB Study: Ensuring Success through Effective Planning (3/3) Thank You! Part III: Models, Evaluation, Open Issues Open Questions Helmut Schütz BEBAC Consultancy Services for Bioequivalence and Bioavailability Studies 1070 Vienna, Austria helmut.schuetz@bebac.at Bioequivalence & Bioavailability Studies | Munich, 252 October 2010 162 • 162
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Part III - BEBAC â¢ Consultancy Services for Bioequivalence

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Part III - BEBAC â¢ Consultancy Services for Bioequivalence