This webinar provides an overview of a recent publication on physiologically based pharmacokinetic (PBPK) modeling in first in human (FIH) predictions, and this was a collaborative effort from GastroPlus® User Group members. Physiologically based pharmacokinetic modeling is routinely used during drug discovery for in-vitro to in-vivo translation and pharmacokinetic modeling in preclinical species. This leads to the application of verified models for first-in-human pharmacokinetic predictions. A consistent cross-industry strategy in this application area would increase confidence in the approach and facilitate further learning. With this in mind, the article aims to enhance a previously published first-in-human physiologically based pharmacokinetic model-building strategy. Based on the experience of scientists from multiple companies participating in the GastroPlus User Group Steering Committee, new Absorption, Distribution, Metabolism, and Excretion knowledge is integrated and decision trees proposed for each essential component of a first-in-human prediction. This presentation provides an overview of the proposed updated decision trees and the four industry case studies for more challenging compounds that illustrate and highlight key components of the strategy.
Director, Simulation Sciences
DMPK Investigator and PBPK Team Leader
Head of Drug-Drug Interactions & Transporters