Statistical Methods for Immunogenicity Assessment provides a comprehensive overview of the analytical techniques and statistical frameworks essential for evaluating immunogenicity in clinical and pre-clinical studies. Authored by experts in the field, this authoritative volume serves as a vital resource for biostatisticians, clinical researchers, and scientists working in pharmaceutical and biotech industries. The text covers critical topics such as assay validation, cut point determination, and risk assessment strategies. With a focus on practical application and regulatory compliance, it enables professionals to design robust studies and interpret complex immunological data with greater accuracy. This hardback reference offers deep insights into the methodologies required to ensure safety and efficacy in modern drug development programs. Product Summary: A technical guide on immunogenicity statistics, statistical methods for clinical trials, and immunological data analysis, published by Taylor & Francis Inc.