With a significant increase in ADCs in clinical development and an increase in the complexity in the design of ADCs, it is important to ensure appropriate analytes are measured using validated bioanalytical methods to inform exposure-response analyses. This discussion is intended to review the FDA Guidance on ADC bioanalysis and examples from approved ADCs.
Learning Objectives:
Understand today’s clinical landscape of ADCs
Learn FDA’s guidance on bioanalytical approach for ADCs
Review the bioanalytical strategy for approved drugs – Polivy and Trodelvy
Consideration for the immunogenicity evaluation of ADCs
