Part II - BEBAC • Consultancy Services for Bioequivalence

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