Statistical Methods for Immunogenicity Assessment

A critical issue in the development of biologics, immunogenicity can cause early termination or limited use of the products if not managed well. This book shows how to use robust statistical methods for detecting, quantifying, assessing, and mitigating immunogenicity risk. Along with covering regulatory requirements, the authors discuss statistical considerations in assay development. They also address the challenges of the cut point performance parameter in practical clinical sample testing. The included computer codes and algorithms facilitate application of the statistical methods.