Statistical Evaluation of Bioequivalence Studies - BEBAC ...

More documents

Recommendations

Info

Sample Size: PlanningDoxicycline (37 studies ref. by Blume/Mutschler 1996)12108frequency642total0101520CVs2530200 mg100 mgstudiesDissolution Testing, Bioavailability & <strong>Bioequivalence</strong> | Budapest, 24 May 2007 48
Sample Size: PowerPower to show BEwith 12 – 32 subjectsfor CV intra =20%Power10.90.80.70.62×2 Cross-Over322824222018160.514120.4CV = 20 %0.30.20.8 0.85 0.9 0.95 1 1.05 1.1 1.15 1.2 1.25µT/µRDissolution Testing, Bioavailability & <strong>Bioequivalence</strong> | Budapest, 24 May 2007 49
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 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

Statistical Evaluation of Bioequivalence Studies - BEBAC ...

Create successful ePaper yourself

Delete template?

Save as template?