Main Title |
Statistical methods for immunogenicity assessment / |
Author |
Yang, Harry,
|
Other Authors |
|
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
|
Holdings |
Library |
Call Number |
Additional Info |
Location |
Last Modified |
Checkout Status |
ELBM |
QR186.Y36 2016 |
|
AWBERC Library/Cincinnati,OH |
11/09/2016 |
|
Collation |
xxii, 237 pages : illustrations ; 24 cm. |
Notes |
"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. |