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 4.1.8Initial group of subjects treated and data analysed.If BE not been demonstrated an additional groupcan be recruited and the results from both groupscombined in a final analysis.Appropriate steps to preserve the overall type I error(patient’s risk).Stopping criteria should be defined a priori.‘Internal PilotStudy Design’First stage data should be treated as an interimanalysis.informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201052 • 68
6/6 | Statistical Design and Analysis IIITwo-Stage DesignEMA GL on BE (2010)Section 4.1.8 (cont’d)Both analyses conducted at adjusted significancelevels (with the confidence intervals accordinglyusing an adjusted coverage probability which willbe higher than 90%). […] 94.12% confidenceintervals for both the analysis of stage 1 and thecombined data from stage 1 and stage 2 would beacceptable, but there are many acceptable alternativesand the choice of how much alpha to spendat the interim analysis is at the company’s discretion.informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201053 • 68
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Part II - BEBAC â¢ Consultancy Services for Bioequivalence