Statistical Methods for Immunogenicity Assessment

By: Harry Yang, Jianchun Zhang, Binbing Yu, Wei Zhao

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eText | 17 July 2015 | Edition Number 1

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Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation stra