A Tutorial on the Development of a Physiologically Inspired PKRO Model for Monoclonal Antibodies

This tutorial introduces the physiologically inspired PKRO (piPKRO) model – a streamlined, mechanistic framework for predicting monoclonal antibody pharmacokinetics and receptor occupancy at the site of action. By integrating physiological tissue volumes, biodistribution, and target-mediated drug disposition into a simple compartmental model, piPKRO enables more accurate, biology-driven insights into nonlinear PK, local drug depletion, and dose selection. Case studies with dupilumab demonstrate how the model can be used for prediction, calibration, and exploration of tissue-specific receptor occupancy.