Statistical Evaluation of Bioequivalence Studies - BEBAC ...

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Parallel Groups: Example• Evaluation (sample data set, period 1 only)• Original data set• Balanced (T 12, R 12)• Equal variances (s² R0.1292, s² T0.1796)F-ratio test p 0.5947Levene test p 0.5867• Modified data set:• Values of subjects 4 – 6 × 3• Subjects 22 – 24 removed• Inbalanced (T 9, R 12)• Unequal variances (s² R0.1292, s² T0.5639)F-ratio test p 0.0272Levene test p 0.1070Dissolution Testing, Bioavailability & Bioequivalence | Budapest, 24 May 2007 36
Parallel Groups: Example• Evaluation (original data set)• Is your software able to give the correct answer?Program / Method‘manual’ (Excel 2000)R 2.5.0 (2007)NCSS 2001 (2001)STATISTICA 5.1H (1997)WinNonlin 5.2 (2007)Kinetica 4.4.1 (2007)EquivTest/PK (2006)equal variances63.51% – 110.19%63.51% – 110.19%63.51% – 110.19%63.51% – 110.19%63.51% – 110.20%63.51% – 110.19%63.51% – 110.18%unequal variances63.48% – 110.25%63.49% – 110.22%63.49% – 110.22%63.49% – 110.22%not implemented!not implemented!not implemented!Dissolution Testing, Bioavailability & Bioequivalence | Budapest, 24 May 2007 37
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 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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