Record Display for the EPA National Library Catalog


Main Title Statistical methods for immunogenicity assessment /
Author Yang, Harry,
Other Authors
Author Title of a Work
Zhang, Jianchun
Yu, Binbing,
Zhao, Wei,
Publisher CRC Press, Taylor & Francis Group,
Year Published 2016
OCLC Number 909324979
ISBN 9781498700344; 1498700349
Subjects Immune response--Risk assessment--Statistical methods ; Biopharmaceutics--Immunology--Statistical methods ; Drugs--Design ; Risk assessment--Methods ; Immunogenetic Phenomena ; Statistics as Topic ; Drug Design
Library Call Number Additional Info Location Last
ELBM  QR186.Y36 2016 AWBERC Library/Cincinnati,OH 11/09/2016
Collation xxii, 237 pages : illustrations ; 24 cm.
"A Chapman & Hall book." Includes bibliographical references and index.
Contents Notes
Preface. List of figures. List of tables. Introduction : 1 Background -- Immunogenicity -- Impact of immunogenicity -- Regulatory environment and guidelines -- Statistics in immunogenicity risk assessment -- Statistical considerations in comparative immunogenicity studies -- Concluding remarks. 2 ADA assay development and validation : ADA assays -- Assay development and validation -- Design of experiment -- method transfer. 3 Determination of ADA assay cut point : Introduction -- Cut point experimental design. 4 Clinical immunogenicity assessment : Introduction -- Monoclonal antibodies for the treatment of rheumatoid arthritis (RA) -- Statistical analysis of ADA status -- Effects of ADA on drug efficacy -- Effect of ADA on AEs -- Relationship between ADA and pharmacokinetics -- Statistical analysis ADA onset and duration -- Statistical analysis of ADA titer -- meta-analysis. 5 Immunogenicity risk control : Introduction -- Risk assessment -- Immunogenicity risk control -- Biomarkers for immunogenicity -- Concluding remarks. 6 Computational tools for immunogenicity analysis : Read data into R -- ADA assay and cut point -- Implementation of statistical analysis of clinical immunogenicity assessment -- Graphical tools for cause and effect and design space analysis -- Immunogenicity biomarker discovery -- Report automation. Bibliography. Index. Provides a single source of information on statistical concepts, principles, methods, and strategies for detection, quanification, assessment, and control of immunogenicity.