Simulations Plus Releases GastroPlus® Version 9.8.2

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today announced the release of version 9.8.2 of its flagship physiologically based biopharmaceutics (PBBM) / pharmacokinetics (PBPK) modeling program, GastroPlus®. For 25 years, Simulations Plus has remained committed to developing and improving state-of-the-art software tools, educating scientists worldwide with the best and most innovative science, and advancing in silico modeling and simulation.

Key enhancements in GastroPlus version 9.8.2 include:

• New enzyme/transporter expression levels and enzyme ontogeny functions to expand the virtual population databases
• New nonlinear model of bile salt effects on solubility to better inform simulation inputs
• New preclinical physiology models for intramuscular and ocular dosing to allow for easier translation across species
• New options for automated metabolism parameter fitting to increase robustness of the optimization engine
• Improved mechanistic model for oral suspension formulations to enhance understanding of in vivo product performance
• Improved automated workflows for fed/fasted virtual bioequivalence simulations to mimic real-world study designs

Dr. Viera Lukacova, Chief Scientist, said: “PBBM/PBPK modeling and simulation is both an art and a science. With every improvement in GastroPlus, we are refining the art and enriching the science to provide our clients with a deeper and more comprehensive understanding of the complex mechanisms involved. We also continue to stress the need to make GastroPlus easier to use and apply, as evidenced by the new system physiology models, automated workflows, and improved flexibility added in this version to satisfy users both new and experienced.”

John DiBella, Simulations Plus Division President, added: “All the feature enhancements offered in this new version of GastroPlus are the result of the ongoing dialog and input from the GastroPlus User Group, requests from our customers, and the shared learnings from our collaborations with regulatory agencies and industry partners globally. We have devoted the past 25 years to research and development and, importantly, to listening to and learning from the leading scientists around the world. With their guidance, our talented team of scientific experts have rapidly advanced GastroPlus to its position as a ‘gold standard’ in PBBM/PBPK modeling and simulation.”

About Simulations Plus, Inc.

Serving clients worldwide for 25 years, Simulations Plus, Inc., is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. We offer solutions that bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, chemical, consumer goods companies, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on Twitter | Read our Environmental, Social, and Governance (ESG) Report.

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