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>IPotvin et al. (2007)in<strong>for</strong>malife sciencesTechnical AspectsOnly one Interim Analysis (after Stage 1)If possible, use software (too wide step sizes in Diletti’stables)Should be called ‘Power Analysis’ not ‘<strong>Bioequivalence</strong>Assessment’ in the protocolNo a-posteriori Power – only a validated method in thedecision treeNo adjustment <strong>for</strong> the PE observed in Stage 1No stop criterion <strong>for</strong> Stage 2! Must be clearly stated inthe protocol (may be unfamiliar to the IEC, becausestandard in Phase <strong>II</strong>I)<strong>Bioequivalence</strong> and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201058 • 68
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