Statistical Methods for Immunogenicity Assessment

ISBN: 9781498700344 出版年：2015 页码：259 Yang, Harry Zhang, Jianchun Yu, Binbing CRC Press

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