Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today announced that it has released version 9.8.1 of its flagship physiologically based biopharmaceutics (PBBM) / pharmacokinetics (PBPK) modeling program, GastroPlus®. For over 20 years, Simulations Plus has been dedicated to 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 improvements in this version include:
More mechanisms, verification, and guidance for our validated drug-drug interaction (DDI) models
- A “Validated” column in the DDI perpetrator table to clearly identify the values that have been validated by our DDI experts for use in simulations
- A new option to include variability in lung deposition in the Population Simulator
- New enhancements when importing chemical structures
- Updated probability contour outputs for the Population Simulator
- Added units for Cmax, AUC0-inf and AUC0-t in .beq files for both individual crossover trials and virtual bioequivalence (VBE) summaries
- Added metabolite Cmax, AUC0-inf and AUC0-t in .beq files for both individual crossover trials and VBE summaries
- Bug fixes reported by our scientists and users
Dr. Michael Bolger, Founding Scientist of Simulation Plus, said: “Understanding DDI is the first step towards safety for drug combination therapies which can deliver promising strategies for complex diseases. The newly enhanced DDI models increase this capability to identify and predict likely challenges, and the supporting documentation outlining model development and verification activities streamlines the use of GastroPlus simulations to inform regulatory decision making. Special thanks to the Simulations Plus DDI task force and our government and commercial collaborators for their efforts and counsel.”
“The theme of this release is ‘improving efficiency for regulatory reviewers,’” added Neil Miller, Vice President of Simulation Sciences. “Both the expanded reporting of VBE results and improved DDI model documentation will facilitate better communication between health authorities and sponsor companies and accelerate the time to market for new drug products. The underlying science and dedication to detail with these refinements further establishes GastroPlus as the “gold standard” PBPK software platform from discovery through post-approval.”
About Simulations Plus, Inc.
Simulations Plus, Inc., is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. With our subsidiaries, Cognigen, DILIsym Services, and Lixoft, we offer solutions which 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.
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