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1、Lecture7StatisticalDesignsforStabilityStudiesOutlineStatisticalConcepts-Biasandvariability-Confounding-InteractionBasicDesignConsideration-Designobjective-Informationneeded-Designfactors-Responsevariables-FDArequirementsStabilityDesigns-Assumption-Designstrategies-Criteriafordesignsel
2、ectionStatisticalConceptsBiasVariabilityConfoundingInteractionInteractionandNoInteraction-11X1-1807519085Nointeractionx2Interactionx2-11X1-180851907510mg20mg-11x1Package-11x1Package10mg20mgAnExampleConditionLotPackageStrengthResponseRunX1X2X3X4Y11111Y1211-1-1Y231-11-1Y341-1-11Y45-111-
3、1Y56-11-11Y67-1-111Y78-1-1-1-1Y8-11X1-1Y7,Y8Y5,Y61Y3,Y4Y1,Y2-11X3-1Y2,Y8Y4,Y61Y3,Y5Y1,Y7X2X4StatisticalDesignDesignobjectiveInformationneededDesignfactorsResponsevariablesFDArequirementsDesignObjectiveMinimizetotalsamplesizeorminimizetotalcostintestingReducenumberofassaysatsametime-Li
4、mitedlaboratorycapacity-LimitedresourcesHavevalidstatisticalresultsInformationneededMarkingrequirements-Packagetypes-Specifications-Desiredshelf-life-Whenanalyze？(submittoFDA)-Wheresold？Manufacturingpractices-Severalstrengthswithsameformula-Commongranulationbatchintomultiplestrengths-
5、CommonencapsulationbatchintomultiplepackagetypesPreviousformulationstudyresults-Factorsthatmightaffectstability-StorageconditionsInformationneededMethodvariability-BetweenandwithinrunCV’sSamplevariability-Howtosamplecontainers？-Howtosamplefromcontainers？Manufacturingcapacity-Whenwillm
6、anufacture？-Whenwillpackage？LaboratorycapacityDesignFactorsStrengthPackagetypeBatchorlotSampling(orstorage)timesStorageconditionsReplicates？AnalystLocation:etc.ResponseVariablesPotencyDissolutionAppearanceHardnessColorMoisture:etc.FDARequirementsSamplingTimes“…Stabilitytestinggenerall
7、ymaybedoneat3-monthintervalsduringthefirstyear,6-monthintervalsduringthesecondyear,andyearlythereafter…”Samplingtimes:0,3,6,9,12,18,24,36,…Numberofbatchesrequired“…Atleastthreebatchesandpreferablymoreshouldbetestedtoallowforsomeestimateofbatch-to-batchandtotestthehypothesisthatasingle
8、expir
