Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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6/6 | Statistical Design and Analysis IIIEU GL on BE (2010)HVDs/HVDPsAverage Bioequivalence (ABE) with ExpandingLimits (ABEL) If you have σ WR(the intra-subject standard deviationof the reference formulation) go to the next step;if not, calculate it from CV WR: Calculate the scaled acceptance range based on theregulatory constant k (0.7601):[ ]U L e σ2ln( CVWR1)σ = +WRk WR, =± ⋅informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201034 • 68
6/6 | Statistical Design and Analysis IIIEU GL on BE (2010)HVDs/HVDPsScaling allowed for C max only (not AUC!)based on CV WR >30% in the study.Limited to a maximum of CV WR 50% (i.e., higherCVs are treated as if CV = 50%).PE restricted with 80% – 125% in any case.No commercial software for sample size estimationcan handle the PE restriction.Expect a solution from thecommunity soon…informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201035 • 68
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Part II - BEBAC â¢ Consultancy Services for Bioequivalence