Harry Yang, Jianchun Zhang, Binbing Yu, Wei Zhao

Statistical Methods for Immunogenicity Assessment (eBook, ePUB)

• Format: ePub

Produktbeschreibung

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

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Erscheinungstermin: 17. Juli 2015
• Englisch
• ISBN-13: 9781040211830
• Artikelnr.: 73302678

Autorenporträt

Harry Yang is a senior director, Jianchun Zhang is a principal statistician, Binbing Yu is an associate director, and Wei Zhao is a senior principal statistician at MedImmune, LLC in Gaithersburg, Maryland, USA.

Inhaltsangabe

Introduction. ADA Assay Development and Validation. Determination of ADA
Assay Cut Point. Clinical Immunogenicity Assessment. Immunogenicity Risk
Control. Computational Tools for Immunogenicity Analysis. Bibliography.
Index.