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>ISensitivity Analysisin<strong>for</strong>malife sciencesMust be done be<strong>for</strong>e the study (a priori)A posteriori power:High values do not support the claim of alreadydemonstrated bioequivalenceLow values do not invalidate a bioequivalent<strong>for</strong>mulationFurther reader:JM Hoenig and DM HeiseyThe Abuse of Power: The Pervasive Fallacy of Power Calculations <strong>for</strong> Data AnalysisThe American Statistician 55/1, 19–24 (2001)http://www.math.uiowa.edu/~rlenth/Power/2badHabits.pdfRV LenthTwo Sample-Size Practices that I don’t recommendJoint Statistical Meetings, Indianapolis (2000)http://www.math.uiowa.edu/~rlenth/Power/2badHabits.pdf<strong>Bioequivalence</strong> and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201044 • 68