Prologue: Application of PBPK Modeling to Support Dose Selection in Underrepresented Populations

Tuesday, October 18, 2022

8:30 AM – 9:00 AM ET

Location:152

Prologue Speaker(s)

Rodrigo Cristofoletti, PhD

Assistant Professor
University of Florida

The goal of this talk is to present the utility of quantitative modelling for extrapolation of drug safety and efficacy to underrepresented populations in controlled clinical trials. The modeling workflow will be illustrated using two case studies focusing on investigating exposure and efficacy of an antifungal in people living with HIV and an anti-inflammatory drug in febrile children with cystic fibrosis.

Learning Objectives:

integrate in vitro biopharmaceutics data with GI physiology
using reverse translation to gain confidence in IVIVE
develop pathophysiology-based PK models
illustrate the usefulness of PBPK modeling to investigate drug exposure and efficacy in underepresented populations