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Statistical methods for immunogenicity assessment

Author: Harry Yang; Jianchun Zhang, (Statistician); Binbing Yu; Wei Zhao
Publisher: Boca Raton, FL : CRC Press LLC, 2015. ©2016
Series: Chapman & Hall/CRC biostatistics series.
Edition/Format:   eBook : Document : EnglishView all editions and formats
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  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Yang, Harry.
Statistical Methods for Immunogenicity Assessment.
Hoboken : CRC Press, ©2015
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Harry Yang; Jianchun Zhang, (Statistician); Binbing Yu; Wei Zhao
ISBN: 9781498700351 1498700357
OCLC Number: 914300970
Description: 1 online resource.
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.
Series Title: Chapman & Hall/CRC biostatistics series.
Responsibility: Harry Yang, Jianchun Zhang, Binbing Yu, Wei Zhao.

Abstract:

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.

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"In summary, this book is a good resource to the professionals and practitioners developing the biological therapies, including statisticians, clinicians, pharmacokineticists, regulatory reviewers, Read more...

 
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