Statistical Evaluation of Bioequivalence Studies - BEBAC ...

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Nuisance: period effectTreatment effect, Test versus ReferenceTreatment effect, Test versus ReferenceRatio: Test / Reference AUC0.6 0.8 1 1.2 1.4 1.6 1.8Seq 1Seq 2AllData(1.065)(0.965)(0.875)Period 1Data only(1.102)(0.837)(0.635)Period 2Data only(1.429)(1.114)(0.868)Ratio: Test / Reference AUC0.5 1 1.5 2 2.5Seq 1Seq 2AllData(1.065)(0.965)(0.875)Period 1Data only(1.102)(0.837)(0.635)Period 2Data only(1.429)(1.114)(0.869)Dissolution Testing, Bioavailability & Bioequivalence | Budapest, 24 May 2007 62
Nuisance: sequence effect• In a ‘standard’ 2×2 cross-over design• the sequence effect is confounded with• the carryover effect, and• the formulation-by-period interaction.• Therefore, a statistically significant sequenceeffect could indicate that there is• a true sequence effect,• a true carryover effect,• a true formulation by period interaction, or• a failure of randomization.Dissolution Testing, Bioavailability & Bioequivalence | Budapest, 24 May 2007 63
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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 50 and 51: Sample Size: PowerPower to show BEw
Page 53: Sample Size: Sensitivity Analysis
Page 58: Low Variability• Drugs / Drug Pro
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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