最新国家级继续医学教育项目之便秘的诊断与治疗-药学医学精品资料.ppt

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2、policiesoftheFDA.The“IntegratedSummaryofImmunogenicity”isoptionalforBLAsFDAmayincludeanISIrecommendationinnewversionof2016guidanceImmunogenicityattheFDAWhoreviewsit?DependsontheclassofproductCDER-monoclonalantibodies,growthfactors,fusionproteins,cytokines,enzymes,therapeutictoxinsCBE

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4、linicalimmunogenicityassaysfor351(a)and351(k)biologicsatCDERInvolvedinwritingFDAImmunogenicityguidancesImmunogenicityWorkingGroupFDAImmunogenicityGuidancesGuidance(2014):ImmunogenicityAssessmentforTherapeuticProteinProductDiscussesproductandpatientriskfactorsthatmaycontributetoimmune

5、responserates.DraftGuidance(2016):AssayDevelopmentforImmunogenicityTestingofTherapeuticProteinsDiscussesthedevelopmentandvalidationofimmunogenicityassaysGuidance(2016):Immunogenicity-RelatedConsiderationsforLowMolecularWeightHeparinProvidesrecommendationsonaddressingimpuritiesandthei

6、rpotentialeffectonimmunogenicityforANDAsGuidance(2015):ScientificConsiderationsInDemonstratingBiosimilarityToAReferenceProductDiscussesimmunogenicityassaysincontextof351(k)pathwayGuidance(2017):ConsiderationsinDemonstratingInterchangeabilitytoaReferenceProductDiscussesimmunogenicitys

7、tudiesrequiredforinterchangeabilityincontextof351(k)pathwayDraftGuidance(2017):ANDAsforCertainHighlyPurifiedSyntheticPeptideDrugProductsThatRefertoListedDrugsofrDNAOriginDiscussesimmunogenicityconsiderationsforrecombinantpeptidesunderANDACDERImmunogenicityReviewCommitteeIRCisanewcro

8、ss-centercom