New version delivers on FDA collaborations and user feedback for expansion of non-oral delivery route models

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced the release of GastroPlus® 9.9, the latest version of its flagship physiologically based pharmacokinetics/biopharmaceutics (PBPK/PBBM) modeling and simulation software.

Key enhancements include:

• Expanded the ocular (OCAT™), oral cavity (OCCAT™), and dermal (TCAT™) models by adding new formulation and PK/PD mechanisms to better capture local and systemic exposure levels in animals and humans
• Extended the ACAT™ model to enhance the evaluation of formulation approaches for local gastrointestinal (GI) disease states
• Improved Biologics Module features to mimic study designs and refine dose optimization simulations for clinical trial success
• Upgraded with ADMET Predictor® version 11 models, enhancing our First in Human Simulator

“Our software updates reflect the needs our customers communicate to us, and GastroPlus 9.9 is no exception,” said Neil Miller, Vice President of Simulation Sciences at Simulations Plus. “We incorporated feedback from more than 100 companies into these latest enhancements, ensuring they truly provide the improved functionality our customers require. And as we do with every software release, we also updated our models with the latest scientific research, leveraging more than 30 peer-reviewed papers to improve the predictive capabilities of our software platform.”

“For many years, we have worked on collaborative projects with the FDA and other regulatory agencies to improve the technology available to the pharmaceutical industry and increase the safety of animal and human trials,” said Dr. Haiying Zhou, Sr. Director of Simulation Technologies at Simulations Plus. “This is one reason our clients know they can rely on data generated with GastroPlus to inform their program design and support regulatory submissions. In GastroPlus 9.9 specifically, our updates to the Additional Dosage Routes (ADR) Module were built with FDA involvement and funding from three separate FDA grants, and these enhancements are now available for the global GastroPlus user community to apply to their research programs to accelerate the development of new therapies to help patients worldwide.”

GastroPlus 9.9 is available now for licensing and download.

About Simulations Plus, Inc.

Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI)/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, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | Twitter | YouTube.

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