Part II - BEBAC • Consultancy Services for Bioequivalence

6/6 | Statistical Design and Analysis IIIApplicationMost common to assess CV and PE needed insample size estimation for a pivotal BE studyTo select between candidate test formulationscompared to one referenceTo find a suitable referenceIf design issues (clinical performance, bioanalytics)are already known, a two-stage sequential designwould be a better alternative!informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201048 • 68