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LiposomeDrugProductsChemistry,Manufacturing,andControls;HumanPharmacokineticsandBioavailability;andLabelingDocumentationGuidanceforIndustryDRAFTGUIDANCEThisguidancedocumentisbeingdistributedforcommentpurposesonly.Commentsandsuggestionsregardingthisdraftdocumentshouldbesubmittedwithin60daysofpublicationintheFederalRegisterofthenoticeannouncingtheavailabilityofthedraftguidance.Submitelectroniccommentsto(HFA-305),FoodandDrugAdministration,5630FishersLane,Room1061,Rockville,MD20852.AllcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishesintheFederalRegister.Forquestionsregardingthisdraftdocumentcontact(CDER)RichardLostritto,301-796-1697.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)October2015PharmaceuticalQuality/CMCRevision1LiposomeDrugProductsChemistry,Manufacturing,andControls;HumanPharmacokineticsandBioavailability;andLabelingDocumentationGuidanceforIndustryAdditionalcopiesareavailablefrom:OfficeofCommunications,DivisionofDrugInformationCenterforDrugEvaluationandResearchFoodandDrugAdministration10001NewHampshireAve.,HillandaleBldg.,4thFloorSilverSpring,MD20993Phone:[phone]or301-796-3400;Fax:[e-mail](CDER)October2015PharmaceuticalQuality/CMCRevision1ContainsNonbindingRecommendationsDraft—NotforImplementationTABLEOFCONTENTSI.INTRODUCTION.............................................................................................................1II.BACKGROUND...............................................................................................................2III.DISCUSSION....................................................................................................................2A.Chemistry,Manufacturing,andControls...................................................................................21.DescriptionandComposition..........................................................................................................22.PhysicochemicalProperties.............................................................................................................33.CriticalQualityAttributes...............................................................................................................44.DescriptionofManufacturingProcessandProcessControls........................................................45.ControlofLipidComponents...........................................................................................................5a.DescriptionandCharacterizationofLipidComponents..........................................................5b.ManufactureofLipidComponents............................................................................................5c.SpecificationsforLipidComponents.........................................................................................6d.StabilityofLipidComponents...................................................................................................76.DrugProductSpecification.............................................................................................................77.Stability............................................................................................................................................88.PostapprovalChangesinManufacturing........................................................................................9B.HumanPharmacokinetics:BioavailabilityandBioequivalence................................................91.ClinicalPharmacologyStudies......................................................................................................10a.PharmacokineticandMassBalanceStudiesforLiposomeDrugProducts............................10b.ComparisonClinicalPharmacologyStudieswithNonliposomeDrugProduct.....................102.Biopharmaceutics..........................................................................................................................11a.DrugReleaseCharacteristics..................................................................................................11b.InVitro/InVivoCorrelation(IVIVC)......................................................................................11c.BioanalyticalMethods.............................................................................................................11d.Liposome-ProteinInteraction.................................................................................................12C.Labeling........................................................................................................................................121.NonproprietaryNamesofDrugProductsApprovedundertheFederalFood,Drug,andCosmeticAct......................