最新眼科常见病及护眼保健.教学讲义PPT.ppt

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1、眼科常见病及护眼保健.IntegratedSummariesofImmunogenicity:AnFDAReviewer’sWishListDisclaimerViewsexpressedinthispresentationarepersonal,andreflectiveofmyexperienceasanimmunogenicityreviewerfortheOfficeofBiotechnologyProducts.MyviewsarenotnecessarilyreflectiveofviewsorcurrentpoliciesoftheFDA.The“Integrated

2、SummaryofImmunogenicity”isoptionalforBLAsFDAmayincludeanISIrecommendationinnewversionof2016guidanceImmunogenicityattheFDAWhoreviewsit?DependsontheclassofproductCDER-monoclonalantibodies,growthfactors,fusionproteins,cytokines,enzymes,therapeutictoxinsCBER-allergenics,bloodandbloodcomponentsinclu

3、dingclottingfactors,cellularandgenetherapies,vaccinesOfficeofBiotechnologyProducts(OBP)CMCfor351(a)and351(k)biologicsunderCDERpurviewCurrently4productdivisionswithmixedportfoliosCollaborateinimmunogenicityriskassessmentsandreviewvalidationofclinicalimmunogenicityassaysfor351(a)and351(k)biologic

4、satCDERInvolvedinwritingFDAImmunogenicityguidancesImmunogenicityWorkingGroupFDAImmunogenicityGuidancesGuidance(2014):ImmunogenicityAssessmentforTherapeuticProteinProductDiscussesproductandpatientriskfactorsthatmaycontributetoimmuneresponserates.DraftGuidance(2016):AssayDevelopmentforImmunogenic

5、ityTestingofTherapeuticProteinsDiscussesthedevelopmentandvalidationofimmunogenicityassaysGuidance(2016):Immunogenicity-RelatedConsiderationsforLowMolecularWeightHeparinProvidesrecommendationsonaddressingimpuritiesandtheirpotentialeffectonimmunogenicityforANDAsGuidance(2015):ScientificConsiderat

6、ionsInDemonstratingBiosimilarityToAReferenceProductDiscussesimmunogenicityassaysincontextof351(k)pathwayGuidance(2017):ConsiderationsinDemonstratingInterchangeabilitytoaReferenceProductDiscussesimmunogenicitystudiesrequiredforinterchangeabilityincontextof351(k)pathwayDraftGuidance(2017):ANDAsfo

7、rCertainHighlyPurifiedSyntheticPeptideDrugProductsThatRefertoListedDrugsofrDNAOriginDiscussesimmunogenicityconsiderationsforrecombinantpeptidesunderANDACDERImmunogenicityReviewCommitteeIRCisanewcross-centercommitteewithmembersfro