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1、2.3.PDRUGPRODUCT(NAME,DOSAGEFORM)2.3.P.1DescriptionandCompositionoftheDrugProduct(1)Adescriptionofthedosageofdrugproductanditscompositionshouldbeprovidedwithatabletopresenttheactionofeachcompositionandthespecification.Overagesshouldbeexplainedandthedissolventwhichisusedbutremovedintheendshouldbein
2、thetable.CompositionamountOveragesactionspecificationthedissolventwhichisusedbutremovedintheend(2)Ifthereisspecialdissolvent,pleasefillthetableasabove.(3)Descriptionofcontainerandmaterialofpackage.2.3.P.2PharmaceuticalDevelopmentSummarizethepurposeofthedevelopment,includingdosage,strengthandreason
3、oftheselection.2.3.P.2.1ComponentsoftheDrugProduct2.3.P.2.1.1DrugsubstanceSummarizethecompatibilityofthedrugsubstancewithexcipients.Referto3.2.P.2.1.1(Page:)forthedetails.Additionally,summarizekeyphysicochemicalcharacteristics(e.g.,solubility,particlesizedistribution,orcrystalform)ofthedrugsubstan
4、cethatcaninfluencetheperformanceofthedrugproductandalsothecontrolofallthischaracteristics.2.3.P.2.1.2ExcipientsGenerallyintroducethetypesandthetestsand/orreferenceofamountselection.Referto3.2.P.2.1.2(Page:)forthedetails.2.3.P.2.2PharmaceuticalDevelopment2.3.P.2.2.1FormulationDevelopmentReferto3.2.
5、P.2.2.1(Page:)fortheprocessofformulationdevelopmentandsupporting8information.Atabulatedsummaryofthevariationandreasonsofformulationofdifferentdevelopmentsteps,aswellassupportingvalidationtestsshouldbeprovided.Forexample:FormulationoflaboratoryscaletestsFormulationofpilotscaletestsFormulationoflarg
6、escaletestsMainvariationandreasonsSupportinginformationExcessivefeeding:Supportinginformationaboutexcessivefeeding.2.3.P.2.2.2PropertiesofdrugproductsSummaryrelevanttotheperformanceofthedrugproduct,suchaspH,ionicstrength,dissolution,redispersion,reconstitution,particlesizedistribution,polymorphism
7、,rheologicalproperties,shouldbeaddressed.Thequalitycomparativetestsresultsbetweentheproductsandinnovatorintheformulationdevelopmentshouldbeprovided.Forexample:(1)Dissolutionoforalsolidpreparations:batchnumber,bat