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.