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.
Summary:
Provides a single source of information on statistical concepts, principles, methods, and strategies for detection, quanification, assessment, and control of immunogenicity.
This resource is supported by the Institute of Museum and Library Services under the provisions of the Library Services and Technology Act as administered by State Library of Iowa.