Translating Preclinical Toxicity to Clinical Toxicity Using PK-PD Modelling Approaches
Time: 10:30 am
day: Track B - Pre-conf-AM
- Reviewing how the ability to translate data from animal toxicology studies to humans is key in optimizing the dose, regimen in early clinical
development and thereby optimizing development
- Showcasing mechanistic PK/ PD models can be a better approach to translate key hematologic toxicities from cynos to humans. These models are widely used to understand hematologic toxicity in humans and can be extended for translation across species
- Sharing two examples of using a model-based approach to translate hematologic toxicities. These examples – one for neutropenia and one for thrombocytopenia will show how to use the model-based approach to predict hematologic toxicities in humans based on cyno data.