Overview and Introduction - BEBAC ⢠Consultancy Services for ...
Overview and Introduction - BEBAC ⢠Consultancy Services for ...
Overview and Introduction - BEBAC ⢠Consultancy Services for ...
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1/7 | <strong>Overview</strong> & <strong>Introduction</strong>Best Design ofBE StudiesHelmut Schütz<strong>BEBAC</strong><strong>Consultancy</strong> <strong>Services</strong> <strong>for</strong>Bioequivalence <strong>and</strong> Bioavailability Studies1070 Vienna, Austriahelmut.schuetz@bebac.atin<strong>for</strong>malife sciencesBioequivalence <strong>and</strong> Bioavailability, Pre-conference workshop | Budapest, 11 May 2009 1 • 12
1/7 | <strong>Overview</strong> & <strong>Introduction</strong>Best Good Design ofBE Studies<strong>Overview</strong> <strong>and</strong> <strong>Introduction</strong>in<strong>for</strong>malife sciencesBioequivalence <strong>and</strong> Bioavailability, Pre-conference workshop | Budapest, 11 May 2009 2 • 12
1/7 | <strong>Overview</strong> & <strong>Introduction</strong>in<strong>for</strong>malife sciencesAnswering the Question:What is Enlightenment?„Enlightenment is man’s emergencefrom his self-imposed immaturity <strong>for</strong>which he himself was responsible.Immaturity <strong>and</strong> dependence are theinability to use one’s own intellectwithout the direction of another. Oneis responsible <strong>for</strong> this immaturity <strong>and</strong>dependence, if its cause is not a lackof intelligence, but a lack of determination <strong>and</strong> courage tothink without the direction of another. Sapere aude!Have courage to use your own underst<strong>and</strong>ing! is there<strong>for</strong>ethe slogan of Enlightenment.” Immanuel Kant (1784)Bioequivalence <strong>and</strong> Bioavailability, Pre-conference workshop | Budapest, 11 May 2009 3 • 12
1/7 | <strong>Overview</strong> & <strong>Introduction</strong>To bear in Remembrance...Whenever a theory appears to youas the only possible one, take this asa sign that you have neither under-stood the theory nor the problemwhich it was intended to solve.Even though it’s applied sciencewe’re dealin’ with, it still is – science!Karl R. PopperLeslie Z. Benetin<strong>for</strong>malife sciencesBioequivalence <strong>and</strong> Bioavailability, Pre-conference workshop | Budapest, 11 May 2009 4 • 12
1/7 | <strong>Overview</strong> & <strong>Introduction</strong>AssumptionsWorld ‘Reality’αβModel ‘Data’H0HATheory ‘Truth’in<strong>for</strong>malife sciencesBioequivalence <strong>and</strong> Bioavailability, Pre-conference workshop | Budapest, 11 May 2009 5 • 12
1/7 | <strong>Overview</strong> & <strong>Introduction</strong>BioequivalenceMain TopicsSurrogate of clinical equivalence orMeasure of pharmaceutical quality?Types of studiesPharmacokinetic (PK)Pharmacodynamic (PD)Clinical (equivalence <strong>and</strong>/or safety/efficacy)in<strong>for</strong>malife sciencesBioequivalence <strong>and</strong> Bioavailability, Pre-conference workshop | Budapest, 11 May 2009 6 • 12
1/7 | <strong>Overview</strong> & <strong>Introduction</strong>Main TopicsTypes of studies (cont.’d)Healthy SubjectsPatientsSingle doseMultiple doseCross-overParallelReference product (another modified release<strong>for</strong>mulation, IR, solution)in<strong>for</strong>malife sciencesBioequivalence <strong>and</strong> Bioavailability, Pre-conference workshop | Budapest, 11 May 2009 7 • 12
1/7 | <strong>Overview</strong> & <strong>Introduction</strong>Main Topicsin<strong>for</strong>malife sciencesTypes of studies (cont.’d)(PK interaction)Food effectDesign IssuesDose regimenFasted / fed stateType of st<strong>and</strong>ard mealsBioanalytics (not GLP!)Parent drug <strong>and</strong>/or metabolite(s)ValidationBioequivalence <strong>and</strong> Bioavailability, Pre-conference workshop | Budapest, 11 May 2009 8 • 12
1/7 | <strong>Overview</strong> & <strong>Introduction</strong>Main TopicsEthics (GCP!)Dose levels / number of administered dosesNumber / volume of blood samplesDrug <strong>and</strong>/or adverse effectsClinical per<strong>for</strong>mance (GCP!)CRO selectionResponsibilities of sponsor / investigatorAudits / monitoringin<strong>for</strong>malife sciencesBioequivalence <strong>and</strong> Bioavailability, Pre-conference workshop | Budapest, 11 May 2009 9 • 12
1/7 | <strong>Overview</strong> & <strong>Introduction</strong>Main Topicsin<strong>for</strong>malife sciencesNCA / PK (PD)Sampling scheduleMetrics (AUC, C max , C min ; AUEC, E max ,…)Design, methods, evaluationSample sizeEstimation from previous <strong>and</strong>/or pilot studies,literatureHighly variable drugsBiostatisticsModels & assumptionsProtocol, evaluation, reportBioequivalence <strong>and</strong> Bioavailability, Pre-conference workshop | Budapest, 11 May 2009 10 • 12
1/7 | <strong>Overview</strong> & <strong>Introduction</strong>‘What if’-scenariosCommon pitfallsMain TopicsProblems in clinical per<strong>for</strong>mance – studies ‘on hold’Failure to meet the needed per<strong>for</strong>mance inbioanalyticsBlind review‘Failed’ studiesDeficiency lettersin<strong>for</strong>malife sciencesBioequivalence <strong>and</strong> Bioavailability, Pre-conference workshop | Budapest, 11 May 2009 11 • 12
1/7 | <strong>Overview</strong> & <strong>Introduction</strong>Another reminderin<strong>for</strong>malife sciencesRoseis a roseis a roseis a rose. Gertrude Stein (1913)Guidelinesare guidelinesare guidelines.Henrike Potthast (ca. 2004)In advanced engineering, you expected failure; you learnedas much from failures as from successes – indeed if younever suffered a failure you probably weren’t pushing theenvelope ambitiously enough.Stephen Baxter; Transcendent, Chapter 36 (2006)Bioequivalence <strong>and</strong> Bioavailability, Pre-conference workshop | Budapest, 11 May 2009 12 • 12
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