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Modeling and Simulation , Kevser Sevim

Scientific Poster Spotlight: Qualification of GastroPlus® PBPK Modeling Software to Support Decision Making in Clinical Development

Hexagons on blue gradient background with Quotient Sciences logo

In recent years, physiologically based pharmacokinetic (PBPK) modeling has become an increasingly important part of drug development programs. Quotient Sciences uses GastroPlus® PBPK modeling software to provide unique solutions for overcoming our customers’ product development challenges, making it vital to assess the software’s ability to perform simulations with adequate precision.

At the Pharmacokinetics UK (PKUK) conference in November 2022, Quotient Sciences’ Modeling and Simulation (M&S) team presented a poster about their project to qualify the GastroPlus software and demonstrate the predictive performance of PBPK models in various clinical situations.

A repository of case studies was collated, covering a wide range of drug types, formulations, and clinical scenarios. Using GastroPlus, individual predictions for the diverse clinical scenarios were compared to observed clinical data, and the prediction performance was evaluated.

The results demonstrated the ability of the GastroPlus PBPK modeling software to predict observed outcomes with adequate precision. This project enables Quotient Sciences to offer customers a qualified PBPK modeling platform for the scenarios contained within the qualification data set. Over time, the repository will be expanded to include a more diverse range of drug types and scenarios.

Poster authors

  • Quotient Sciences: Kevser Sevim, Alison J Wilby, Shriram M Pathak, Christine Meddes
  • University of Nottingham: Daniel Vaughan