Statistical Evaluation of Bioequivalence Studies - BEBAC ...

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Sample Size: PowerPower to show BEwith 12 – 32 subjectsfor CV intra =20%10.90.80.72×2 Cross-Over10.950.92×2 Cross-Over11.051.1Power0.60.51.150.40.30.850.212 16 20 24 28 3212 16 20 24 28 32Number of subjectsNumber of subjectsCV = 20 %CV = 20 %Dissolution Testing, Bioavailability & Bioequivalence | Budapest, 24 May 2007 50
Sample Size: PowerEffect of drop-outson power to showBE (CV intra 20%,GMR 0.95):• n=24: 0.891• n=20: 0.829 ( -7 %)Power10.90.80.72×2 Cross-Over242220181614• n=16: 0.730 (-12 %)0.6CV = 20 %0.50.85 0.9 0.95 1 1.05 1.1 1.15µT/µRDissolution Testing, Bioavailability & Bioequivalence | Budapest, 24 May 2007 51
Page 1: Statistical Evaluation ofBioequival
Page 7: Assumptions: StatisticsMultiplicati
Page 12: Nonparametrics5. In which cases may
Page 16 and 17: Acceptance range for C max2. Assess
Page 18 and 19: Outliers• Problems• Parametric
Page 20 and 21: Outliers• Solution II• Stay wit
Page 22 and 23: Re-testing of subjectsn=24: 83.3%-1
Page 24 and 25: Add-on Design• Reasonable,• if
Page 26 and 27: Group Sequential Design± EU• Per
Page 29 and 30: Studiesof >2 formulations• Disadv
Page 31 and 32: Studiesof >2 formulations• Often
Page 33: Parallel Groups• Design Issues•
Page 36 and 37: Parallel Groups: Example• Evaluat
Page 38 and 39: Parallel Groups: Example• Evaluat
Page 40 and 41: Sample Size• Minimum Number of Su
Page 42 and 43: Sample Size: Planning• NfG on the
Page 48 and 49: Sample Size: PlanningDoxicycline (3
Page 53: Sample Size: Sensitivity Analysis
Page 58: Low Variability• Drugs / Drug Pro
Page 63 and 64: Nuisance: sequence effect• In a
Page 65 and 66: Nuisance: sequence effect• In a l
Page 67 and 68: Nuisance: sequence effect• Conclu
Page 69 and 70: Are we making progress?• About 3
Page 71 and 72: ...to be rememberedWhenever a theor
Page 73 and 74: Statistical Evaluation ofBioequival

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