ABSTRACT

Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation stra

chapter 1|22 pages

Introduction

chapter 2|34 pages

ADA Assay Development and Validation

chapter 3|32 pages

Determination of ADA Assay Cut Point

chapter 4|68 pages

Clinical Immunogenicity Assessment

chapter 5|36 pages

Immunogenicity Risk Control