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Inthiscourse,avarietyofcasestudieswillbeusedtopresentthemostimportantaspectstoconsiderforasounddeterminationofproductshelf-lifeorstability Stabilitystudiesshouldbedesignedtoprovideasuitablefittostatistical(e.g.,kinetics)models.Amodelshouldincludemechanistic,experimentalIntroduction.The purposeofastabilitystudyistoestablish,basedontestingaminimumofthreebatchesofthedrugsubstanceorveterinarythemedicinalproduct,aretestperiodor shelfStatisticalconsiderationsfordesignandanalysisofstability,comparabilityandformulationtestsThisbookconsistsofchaptersContentsPrefacexiiiAboutthe AuthorxvSeriesAmodelshouldincludemechanistic,experimental,andstatisticalaspectsTablelistssomeexamplesofIllustratinghowstabilitystudiesplayan importantroleindrugsafetyandqualityassurance,"StatisticalDesignandAnalysisofStabilityStudies"presentstheprinciplesandmethodologiesinthedesignand analysisofstabilitystudieschapterThedesignandexecutionofformalstabilitystudiesshouldfollowtheprinciplesoutlinedintheparentguidelineInthisBecause ithasbeenunderexposedinliterature,thisarticlepresentsacombinedanalysis,anddiscussesindetailtheuseofinitialresults,theimposedrestrictionsonbatch intercepts,andpoolabilityofbatchesacrossstorageconditionsAllstatisticalmethodsandtheirinterpretationsregardingdesignandanalysisofstabilitystudiesare illustratedthroughrealexampleswheneverpossibleAfterintroducingthebasicconceptsofstabilitytesting,thebookfocusesonshort-termstabilityThesuccessof astabilityprogramrequiresanapprovedstabilitystudyprotocolinwhichreasonsforchoosinganappropriatestabilitydesignshouldbedescribedindetailThis articleconsidersdesignedexperimentsforstability,comparability,andformulationtestingthatareanalyzedwithregressionmodelsinwhichthedegradationrateis afixedeffectWhenastabilitystudyincludesallcombinationsofdosagestrength,packaging,andstoragetimes,thestabilitydesignisreferredtoasa“full-factorial” designInaddition,theFDAstabilityguidelineindicatesthatastabilitystudyprotocolmustdescribe:(a)howthestabilitystudyistobedesignedandcarriedout, and(b)Shelf-Life&StabilityStudies–Design&Analysis.Thescopeofthisbookisrestrictedtostatisticaldesignandanalysisofstabilitystudies.Startingfrom theassessmentofthedifferencesbetweenshelf-lifeandstabilitystudies,participantswilllearnforeach, TheDesignandStatisticalAnalysisofAnimal Experiments:IntroductiontothisIssueemberILARjournalNationalResearchCouncil,InstituteofLaboratoryAnimalResources(3), Thedesignandanalysisof astabilitystudyrequiresthespecificationofakinetic,predictivemodelfortheinstabilityofeachkeymeasureAbstractStatisticaldesignisaimedatcontrolling (minimizing)theuncertaintyThestatisticalaspectsofthesestabilitydesignswillbediscussedinrelationtotherecentICHguidelinesandacasestudyispresented toillustratethepotentialproblemsofan,·Understandingthestabilityofapharmaceuticalproduct(oranyofitscomponents)isimportantforproperqualitydesign atmanystagesoftheproductlifecycle