Simulations Plus Releases GastroPlus® Version 9.8.1

Rhea-AI Summary

Simulations Plus (Nasdaq: SLP) has launched version 9.8.1 of its GastroPlus® software, enhancing its pharmacokinetics modeling capabilities. Key upgrades include improved drug-drug interaction (DDI) models, new options for lung deposition variability, and better data import processes. These advancements aim to streamline regulatory reviews and enhance communication between health authorities and drug sponsors. The updates are expected to expedite the marketing of new drug products, reinforcing GastroPlus as a leading PBPK software platform.

Positive

• Release of GastroPlus® version 9.8.1 with enhanced DDI models.
• Improvements aimed at facilitating regulatory reviews.
• New functionalities to aid in drug formulation and safety evaluations.

Negative

• None.

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 C_max, AUC_0-inf and AUC_0-t in .beq files for both individual crossover trials and virtual bioequivalence (VBE) summaries
• Added metabolite C_max, AUC_0-inf and AUC_0-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.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like “believe,” “expect” and “anticipate” mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports and filed with the U.S. Securities and Exchange Commission.

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FAQ

What are the key features of GastroPlus® version 9.8.1 released by Simulations Plus?

The key features include enhanced drug-drug interaction models, variability in lung deposition, improved data imports, and updated probability contour outputs.

How does the new GastroPlus® version benefit regulatory reviewers?

The new version improves communication between health authorities and sponsors, aiming to accelerate the time to market for new drugs.

What is the stock symbol for Simulations Plus?

The stock symbol for Simulations Plus is SLP.