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

Funded collaborative research effort strengthens the population simulation functionality in GastroPlus®

LANCASTER, Calif.-- Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, 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 cohosted 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.”

About Simulations Plus, Inc.

Simulations Plus, Inc., is a premier developer of drug discovery/development software and a leading provider of both preclinical and clinical pharmacometric consulting services for regulatory submissions and quantitative systems pharmacology models for drug-induced liver injury, drug-induced kidney injury, and nonalcoholic fatty liver disease. Our software is used to conduct drug research by major pharmaceutical, biotechnology, chemical, consumer goods companies and regulatory agencies worldwide. Our innovations in integrating new and existing science in medicinal chemistry, computational chemistry, pharmaceutical science, biology, and physiology into our software have made us the leading provider for physiologically based pharmacokinetic modeling and simulation. Visit us online www.simulations-plus.com.