Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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6/6 | Statistical Design and Analysis IIISolutionsDo 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.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 201050 • 68
6/6 | Statistical Design and Analysis IIISample Size: Pilot StudiesPilot Studies (cont’d)Moderate sized pilot studies (sample size ~12–24)lead to more consistent results(both CV intra and PE). If you stated a procedure in your protocol, even BE may beclaimed in the pilot study, and no further study will benecessary. If you have some previous hints of high intra-subjectvariability (>30%), a pilot study size of at least 24 subjectsis reasonable.A Sequential Design may also avoid an unnecessary largepivotal study.informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201051 • 68
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Part II - BEBAC â¢ Consultancy Services for Bioequivalence