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1、2.3.PDRUGPRODUCT(NAME,DOSAGEFORM)2.3.P.1DescriptionandCompositionoftheDrugProduct（1）Adescriptionofthedosageofdrugproductanditscompositionshouldbeprovidedwithatabletopresenttheactionofeachcompositionandthespecification.Overagesshouldbeexplainedandthedissolventwh
2、ichisusedbutremovedintheendshouldbeinthetable.CompositionamountOveragesactionspecificationthedissolventwhichisusedbutremovedintheend(2)Ifthereisspecialdissolvent,pleasefillthetableasabove.(3)Descriptionofcontainerandmaterialofpackage.2.3.P.2PharmaceuticalDevelo
3、pmentSummarizethepurposeofthedevelopment,includingdosage,strengthandreasonoftheselection.2.3.P.2.1ComponentsoftheDrugProduct2.3.P.2.1.1DrugsubstanceSummarizethecompatibilityofthedrugsubstancewithexcipients.Referto3.2.P.2.1.1(Page:)forthedetails.Additionally,sum
4、marizekeyphysicochemicalcharacteristics(e.g.,solubility,particlesizedistribution,orcrystalform)ofthedrugsubstancethatcaninfluencetheperformanceofthedrugproductandalsothecontrolofallthischaracteristics.2.3.P.2.1.2ExcipientsGenerallyintroducethetypesandthetestsan
5、d/orreferenceofamountselection.Referto3.2.P.2.1.2(Page:)forthedetails.2.3.P.2.2PharmaceuticalDevelopment2.3.P.2.2.1FormulationDevelopmentReferto3.2.P.2.2.1(Page:)fortheprocessofformulationdevelopmentandsupporting8information.Atabulatedsummaryofthevariationandre
6、asonsofformulationofdifferentdevelopmentsteps,aswellassupportingvalidationtestsshouldbeprovided.Forexample:FormulationoflaboratoryscaletestsFormulationofpilotscaletestsFormulationoflargescaletestsMainvariationandreasonsSupportinginformationExcessivefeeding:Supp
7、ortinginformationaboutexcessivefeeding.2.3.P.2.2.2PropertiesofdrugproductsSummaryrelevanttotheperformanceofthedrugproduct,suchaspH,ionicstrength,dissolution,redispersion,reconstitution,particlesizedistribution,polymorphism,rheologicalproperties,shouldbeaddresse
8、d.Thequalitycomparativetestsresultsbetweentheproductsandinnovatorintheformulationdevelopmentshouldbeprovided.Forexample:(1)Dissolutionoforalsolidpreparations:batchnumber,bat
