Quotient Sciences’ Modeling and Simulation (M&S) team has recently completed qualification of GastroPlus, the software they use for physiologically based pharmacokinetic (PBPK) modeling. This 2-year project reflects Quotient Sciences’ commitment to conducting high-quality modeling work with regard to data integrity. In addition, this work proactively takes into account recently issued regulatory draft guidelines by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) around the conduct and reporting of PBPK modeling.
At Quotient Sciences, GastroPlus is routinely used to simulate dissolution and absorption processes and drug pharmacokinetics, in support of both integrated Translational Pharmaceutics® programs and as a stand-alone consultative service. The output from GastroPlus may be used to inform key formulation and clinical development decisions.
The GastroPlus qualification project involved collating and preparing data, building a GastroPlus database, executing drug records within the database, and analyzing the model output and performance. In total, 100 database records with a variety of different properties were compiled, and five instances of the software across different machines were evaluated. Overall, the performance of GastroPlus was shown to be qualified to predict real-life scenarios and provide reproducibility across machines. Sarah Stevens, Senior Vice President and Head of Early Development at Quotient Sciences, said, “We are delighted that the qualification of GastroPlus has been successfully completed. This important project will ensure that we continue to produce high-quality modeling data that aids in critical formulation decision-making, in order to best support our customers’ drug development programs.”
Quotient Sciences will be presenting on this project at the upcoming Pharmacokinetics UK (PKUK) conference in Canterbury Cathedral, UK, on November 2-4, where Kevser Sevim (Modeling and Simulation Research Fellow) and Alison Wilby (Director of Modeling and Simulation) will be presenting a poster entitled “Qualification of GastroPlus® Physiologically-Based Pharmacokinetic (PBPK) Modelling Software to Support Decision Making in Clinical Development”.
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GastroPlus® is a registered trademark of Simulations Plus.