PBPK Modeling & Simulation Predicts Low Drug-Drug Interaction Liability & No Significant Impact of Hepatic Impairment for An ADC With the Payload AF-HPA
Time: 2:30 pm
day: Conference Day 2
Details:
- Case study describing a PBPK modeling and simulation approach to predict the impact of drug-drug interactions (DDI) and hepatic impairment on clinical PK of an ADC with an auristatin-based payload (auristatin F-hydroxypropylamide [AF-HPA])
- Model development and verification using a combination of in vitro, pre-clinical, and clinical ADME/PK data using mixed ‘bottom-up’ and ‘top-down’ approaches
- Overview of model simulations to predict the liability of unconjugated AF-HPA as a victim or perpetrator of clinical DDI and to predict the impact of hepatic impairment on the exposure of unconjugated AF-HPA
