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1、LectureSixAcceleratedTestingOutlineIntroductionChemicalKineticReactionStatisticalAnalysisandPredictionExaminationsofModelAssumptionsNumericalExamplesDiscussion9.1IntroductionAsdefinedintheFDAguideline,theexpirationdatingperiodorshelflifeofadrugproductis
2、thetimeintervalthatthedrugproductisexpectedtoremainwithinspecificationsaftermanufacture.Theshelflifeofadrugproductisusuallyestablishedbasedontheprimarystabilitydata.Theprimarystabilitydataareobtainedfromlong-termstabilitystudiesconductedunderanapproveds
3、tabilityprotocolwithambientstorageconditions.Drugproductsunderambientstorageconditionsinlong-termstabilitystudies,however,usuallydegradeveryslowly.Therefore,formostdrugproducts,itmaytakemorethanayeartoobservesignificantdegradation.Asiswellknown,thedevel
4、opmentofadrugproductisalengthyprocessthatusuallyinvolvesmanystages.Thegoalsandmeaningsofdrugstabilityfunctionsmaybedifferentfromstagetostage.Forexample,thepurposeofstabilitystudiesbeforefilinganINDistwofold.First,itistoverifythatthestabilityofthedrugpro
5、ductwillbemaintainedwithinspecificationsforanimalstudiessuchaslexicologicaltrials.Second,itistoprovideusefulstabilityinformationformodificationoftheformulationofthedrugproduct.Attheveryearlystageofdrugdevelopment,however,theprimarygoalofstabilityfunctio
6、nsistodeterminetheratesofchemicalandphysicalreactionsandtheirrelationshipswithstorageconditionssuchastemperature,moisture,light,andothers.Toachievethisgoal,acceleratedstabilitytestingisusuallyconducted.AsdefinedintheFDAguideline,anacceleratedstabilityte
7、stisashort-termstabilitystudyconductedunderexaggerated(orstressed)conditionstoincreasetherateofchemicalorphysicaldegradationofadrugsubstanceordrugproduct.Acceleratedtestingisalsoknownasstressedtesting.AsstatedintheFDAguideline,exaggeratedstorageconditio
8、nsmayincludetemperature(e.g.,5,50,or75°C),humidityof75%orgreater,andexposuretovariouswavelengthsofelectromagneticradiation,andstorageinanopencontainer.Theuseofexaggeratedstorageconditionsistoacceleratethereactionratesothatsignifi
