Statistical Evaluation of Bioequivalence Studies - BEBAC ...

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Studiesof >2 formulations• Bonferroni-correction needed if more than1 formulation will be marketed (for 3 simultaneouscomparisons without correctionpatient’s risk increases from 5% to 14%).kP α=0.05P α=0.10α adj.P αadj.α adj.P αadj.15.00%10.00%0.05005.00%0.10010.00%29.75%19.00%0.02504.94%0.0509.75%314.26%27.10%0.01674.92%0.0336.67%418.55%34.39%0.01254.91%0.0259.63%522.62%40.95%0.01004.90%0.0209.61%626.49%46.86%0.00834.90%0.0179.59%Dissolution Testing, Bioavailability & Bioequivalence | Budapest, 24 May 2007 30
Studiesof >2 formulations• Often a wrong design is applied, namely• a repeated latin square, instead of• a Williams’ design.• Example for 3 treatments (T 1 , T 2 , R)3 sequence latin square 6 sequence Williams’ designSeq.P 1P 2P 3Seq.P 1P 2P 31T 1T 2R1T 1T 2R2T 2RT 12T 2RT 13RT 1T 23RT 1T 24T 1RT 25T 2T 1R6RT 2T 1Dissolution Testing, Bioavailability & Bioequivalence | Budapest, 24 May 2007 31
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: Studiesof >2 formulations• Disadv
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 50 and 51: Sample Size: PowerPower to show BEw
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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