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>ISolutionsDo not use the pilot study’s CV, but calculatean upper confidence interval!Gould recommends a 75% CI (i.e., a producer’s riskof 25%).Unless you are under time pressure, a two-stagedesign will help in dealing with the uncertainestimate from the pilot.in<strong>for</strong>malife sciencesLA GouldGroup Sequential Extension of a Standard <strong>Bioequivalence</strong> Testing ProcedureJ Pharmacokin Biopharm 23/1, 57-86 (1995)<strong>Bioequivalence</strong> and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201050 • 68