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>ISequential Designsin<strong>for</strong>malife sciencesCurrent work by D Potvin et al. (2007) seemspromisingWork backed by support <strong>for</strong>m FDA, USP,Health Canada,…Likely to be implemented by US-FDAShould be acceptable as a Two-Stage Design inthe EUTwo of <strong>BEBAC</strong>’s protocols approved by BfArMand competent EC in May and December 2009Potvin D, Diliberti CE, Hauck WW, Parr AF, Schuirmann DJ, and RA SmithSequential design approaches <strong>for</strong> bioequivalence studies with crossover designsPharmaceut Statist (2007), DOI: 10.1002/pst.294http://www3.interscience.wiley.com/cgi-bin/abstract/115805765/ABSTRACT<strong>Bioequivalence</strong> and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201056 • 68
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