Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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6/6 | Statistical Design and Analysis IIITwo-Stage DesignEMA GL on BE (2010)Section 4.1.8 (cont’d)Plan to use a two-stage approach must be prespecifiedin the protocol along with the adjustedsignificance levels to be used for each of theanalyses.When analysing the combined data from the twostages, a term for stage should be included in theANOVA model.informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201054 • 68
6/6 | Statistical Design and Analysis IIISequential DesignsHave a long and accepted tradition in laterphases of clinical research (mainly Phase III)Based on work by Armitage et al. (1969),McPherson (1974), Pocock (1977), O’Brien andFleming (1979) and othersFirst proposal by LA Gould (1995) in the area ofBE did not get regulatory acceptance in Europe, butStated in the current Canadian Draft Guidance(November 2009).informalife sciencesLA GouldGroup Sequential Extension of a Standard Bioequivalence Testing ProcedureJ Pharmacokin Biopharm 23/1, 57-86 (1995)Bioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201055 • 68
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Part II - BEBAC â¢ Consultancy Services for Bioequivalence