Pharma Focus Asia

Simulations Plus Partners with Large Pharmaceutical Company to Develop the Virtual Bioequivalence Trial Simulator™ Module

Friday, October 18, 2019

Simulations Plus, Inc., the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that it has entered into a new funded collaboration with a large pharmaceutical company to develop the Virtual Bioequivalence (BE) Trial Simulator™ in GastroPlus®.

“We are beyond pleased to announce this collaboration, which will enhance the GastroPlus physiologically based biopharmaceutics (PBBM) / physiologically based pharmacokinetic (PBPK) platform to evaluate population and formulation variability on the BE of different products,” said Viera Lukacova, director of Simulation Sciences for Simulations Plus. “Working closely with our partner’s team of biopharmaceutics scientists, we intend to improve virtual BE trial simulation methodologies and efficiently address regulatory concerns as model results are reviewed.”

John DiBella, Lancaster division president for Simulations Plus, added: “We recently presented at the workshop co-hosted by the U.S. FDA and University of Maryland CERSI on the application of translational modeling strategies to support drug product development. It was evident that the use of PBBM / PBPK technology will significantly impact development and simplify regulatory decisions in a variety of ways. Our collaborator has engaged with global health authorities on numerous projects, and they identified a critical need to automate simulation activities and streamline the process of submitting data packages for regulatory purposes within a supported, validated platform. Similar to other collaborations which funded development of new functionality, Simulations Plus maintains the right to license this module to all clients, and we aim to have the first commercial version available in 2020. We welcome this interaction and invite future collaborations to drive advances to modeling and simulation sciences.”

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