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E-BOOK
Title Statistical methods for immunogenicity assessment / Harry Yang, Jianchun Zhang, Binbing Yu, Wei Zhao.
Imprint Boca Raton, FL : CRC Press LLC, 2015.
©2016

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Description 1 online resource
Series Chapman & Hall/CRC Biostatistics series
Chapman & Hall/CRC biostatistics series.
Bibliog. Includes bibliographical references.
Note Available only to authorized UTEP users.
Vendor-supplied metadata.
Subject Immune response.
Immunity.
Immunogenetic Phenomena.
Statistics as Topic.
Drug Design.
Risk Assessment -- methods.
Contents Front Cover; Contents; Preface; List of Figures; List of Tables; 1. Introduction; 2. ADA Assay Development and Validation; 3. Determination of ADA Assay Cut Point; 4. Clinical Immunogenicity Assessment; 5. Immunogenicity Risk Control; 6. Computational Tools for Immunogenicity Analysis; Bibliography.
Summary 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 strategies. Statistical Methods for Immunogenicity Assessment provides a single source of information on statistical concepts, principles, methods, and strategies for detection, quantification, assessment, and control of immunogenicity. The book first giv.
Other Author Zhang, Jianchun (Statistician), author.
Yu, Binbing, author.
Zhao, Wei, 1975- author.
Other Title Print version: Yang, Harry. Statistical Methods for Immunogenicity Assessment. Hoboken : CRC Press, ©2015 9781498700344