Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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6/6 | Statistical Design and Analysis IIIα- vs. β-Errorinformalife sciencesβ-Error (aka error type II): producer’s risk to getno approval for a bioequivalent formulationGenerally set in study planning to ≤0.2, wherepower = 1 - β = ≥80%No guidelines about power (‘appropriate’), but70% only in exceptional cases>90% may raise questions from the Ethics Committee(suspection of ‘forced bioequivalence’)There is no a posteriori (aka post hoc) power!Either a study has shown BE or not.Phoenix’/WinNonlin’s output is statistical nonsense!Bioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201024 • 68
6/6 | Statistical Design and Analysis IIIPower vs. Sample Sizeinformalife sciencesIt is not possible to directly calculate theneeded sample size.Power is calculated instead, and the lowestsample size which fulfills the minimum targetpower is used.Example: α 0.05, target power 80%(β=0.2), T/R 0.95, CV intra 20% →minimum sample size 19 (power 81%),rounded up to the next even number ina 2×2 study (power 83%).Bioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 2010n power16 73.54%17 76.51%18 79.12%19 81.43%20 83.47%25 • 68
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Part II - BEBAC â¢ Consultancy Services for Bioequivalence