Statistical Methods for Immunogenicity Assessment
Published on 17. July 2015
259 pages
978-1-040-21183-0 (ISBN)
Description
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
Reviews / Votes
"In summary, this book is a good resource to the professionals and practitioners developing the biological therapies, including statisticians, clinicians, pharmacokineticists, regulatory reviewers, toxicologists, clinical assay developers, and biopharmaceutical engineers."~Journal of Biopharmaceutical Statistics
"The authors' work brings light into some of the issues surrounding immunogenicity of drugs. It is of great help to both clinical and nonclinical professionals, while some of the concepts can also be applied to situations when an immune response towards a drug (a vaccine) is desirable."
~Paul Tudor Tamas
More details
Series
Language
English
Place of publication
London
United Kingdom
Publishing group
Taylor & Francis Ltd
Target group
College/higher education
File size
3,32 MB
ISBN-13
978-1-040-21183-0 (9781040211830)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Harry Yang | Jianchun Zhang | Binbing Yu
Statistical Methods for Immunogenicity Assessment
Book
12/2020
1st Edition
Chapman & Hall/CRC
€63.12
Shipment within 15-20 days
Harry Yang | Jianchun Zhang | Binbing Yu
Statistical Methods for Immunogenicity Assessment
Book
09/2015
1st Edition
Chapman & Hall/CRC
€117.50
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Persons
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.
Content
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.
