免疫原性评价的统计方法

nImmunogenicityAssessment..................131.4.2.2LatestDevelopmentofEMAImmunogenicityGuidelines...................141.4.3JapaneseRegulatoryRequirementsofImmunogenicity141.5StatisticsinImmunogenicityRiskAssessment........151.5.1InSilicoPredictionofImmunogenicity.........161.5.2ADADetectionandQuantification...........161.5.3ClinicalCharacterizationofADA............171.5.3.1CharacteristicsofADAImmuneResponse.171.5.3.2CorrelationbetweenADAandPK/PD,ClinicalSafetyandEfficacy..........181.5.3.3RelationshipofADAwithClinicalEfficacyandSafety...................181.5.3.4IdentificationofRiskFactors.........181.5.4ControlofImmunogenicityRisk............191.5.4.1ControlofProcess/ProductFactors.....191.5.4.2BiomarkersforImmunogenicity.......191.parativeImmunogenicityStudies..............................20ix