Statistical Evaluation of Bioequivalence Studies - BEBAC ...

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Bell curve (and beyond?)• Abraham de Moivre (1667-1754),Pierre-Simon Laplace (1749-1827)Central limit theorem 1733, 1812• Carl F. Gauß (1777-1855)Normal distribution 1795• William S. Gosset, aka Student(1876-1937)t-distribution 1908• Frank Wilcoxon (1892-1965)Nonparametric tests 1945Dissolution Testing, Bioavailability & <strong>Bioequivalence</strong> | Budapest, 24 May 2007 70
...to be rememberedWhenever a theory appears to you asthe only possible one, take this as asign that you have neither understoodthe theory nor the problem which itwas intended to solve.Karl R. PopperEven though it’s applied science we’redealin’ with, it still is – science!Leslie Z. BenetDissolution Testing, Bioavailability & <strong>Bioequivalence</strong> | Budapest, 24 May 2007 71
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Statistical Evaluation ofBioequival
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Assumptions: StatisticsMultiplicati
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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 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: Are we making progress?• About 3
Page 73 and 74: Statistical Evaluation ofBioequival
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