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Industry Summary Articles

Monday, May 19, 2025

Simulations Plus Releases DILIsym® 11

Simulations Plus, Inc. (“Simulations Plus”), a leading provider of cheminformatics, biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, announced the release of DILIsym ® 11, the latest version of its flagship quantitative systems toxicology (QST) platform.

“Advancing toxicology research and improving the prediction of drug-induced liver injury (DILI) are essential to developing safer treatments,” said Shawn O’Connor, Chief Executive Officer of Simulations Plus. “DILIsym continues to set the standard by enabling researchers to assess potential liver safety risks, as well as explore dosing strategies that optimize patient safety. We are proud to support innovation that directly impacts patient health and drug development success.”

“The addition of pediatric representation is an important milestone in predictive toxicology,” said Dr. Scott Q. Siler, Chief Scientific Officer of QSP Solutions of Simulations Plus. “By advancing the evaluation of potential liver safety risks in children, DILIsym 11 will support the development of safer and more effective therapies for children across the globe. We are proud of our role in developing leading-edge modeling tools that help bring better treatment options to vulnerable patient populations.”

DILIsym is a software platform designed to predict potential DILI hazards and provide insight into the mechanisms responsible for observed DILI responses. It is the most widely used QST modeling software for DILI prediction and is utilized as a source of QST modeling-based data assessed by the U.S. Food and Drug Administration’s (FDA) DILI team.

DILIsym 11 offers new pediatric representation for exploratory predictions regarding liver safety to children, and a new T-cell model that allows for better understanding of putative contributions of CD8+ T-cell mediated hepatocellular injury. It also includes improved representation of bile acid and cholestatic liver injury, updated antioxidant adaptation mechanisms, and more.

To view the original press release, please click here.

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