Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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6/6 | Statistical Design and Analysis IIIJustificationGood Scientific Practice!Every influental factor can be tested in a pilot study.Sampling schedule: matching C max, lag-time (firstpoint C maxproblem), reliable estimate of λ zBioanalytical method: LLOQ, ULOQ, linear range,metabolite interferences, ICSRFood, posture,…Variabilty of PK metricsLocation of PEinformalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201046 • 68
6/6 | Statistical Design and Analysis IIIJustificationBest description by FDA (2003)The study can be used to validate analytical methodology,assess variability, optimize sample collectiontime intervals, and provide other information.For example, for conventional immediate-releaseproducts, careful timing of initial samples may avoida subsequent finding in a full-scale study that thefirst sample collection occurs after the plasma concentrationpeak. For modified-release products, apilot study can help determine the samplingschedule to assess lag time and dose dumping.informalife sciencesBioequivalence and Bioavailability, Pre-Conference Workshop | Ljubljana, 17 May 201047 • 68
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Part II - BEBAC â¢ Consultancy Services for Bioequivalence

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Part II - BEBAC â¢ Consultancy Services for Bioequivalence