Statistical Evaluation of Bioequivalence Studies - BEBAC ...

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Conclusions, Outlook• David Bourne’s (Uni. Oklahoma)e-mail list• A rather active list (3200 members,about 50 postings/week) coveringalmost any aspect of PK / PD / BA…• Subscriptionhttp://www.boomer.org/pkin/• Search pagehttp://www.boomer.org/pkin/simple.html• BA and BE Forum (BEBAC Vienna)• Specialized in dissolution / BA / BE /bioanalytics.• No registration necessary to readpostings.http://forum.bebac.at/• Registration (to post own questions)http://forum.bebac.at/register.phpDissolution Testing, Bioavailability & Bioequivalence | Budapest, 24 May 2007 72
Statistical Evaluation ofBioequivalence StudiesThank You!Helmut SchützBEBACConsultancy Services forBioequivalence and Bioavailability Studies1070 Vienna, Austriahelmut.schuetz@bebac.atDissolution Testing, Bioavailability & Bioequivalence | Budapest, 24 May 2007 73
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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 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: ...to be rememberedWhenever a theor
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