Lixoft Adds New Bioequivalence Module in MonolixSuite® Version 2021R1

Rhea-AI Summary

Simulations Plus, Inc. (NASDAQ: SLP) announced an update to its MonolixSuite platform, enhancing PKanalix, Monolix, and Simulx modules. The update includes a new bioequivalence module with a user-friendly graphical interface for managing various study designs. New features such as R functions for reporting, a parent-metabolite library, and faster calculations for complex models have been introduced. These advancements aim to streamline the workflow for pharmacometricians, helping users conduct more efficient data analyses and simulations.

Positive

• Introduction of a new bioequivalence module in PKanalix with an enhanced user interface.
• Faster calculations for complex models and improved performance overall.
• New features in Monolix, including generalized automatic initialization and improved plotting capabilities.

Negative

• None.

Update includes enhanced PKanalix, Monolix, and Simulx modules

LANCASTER, Calif.--(BUSINESS WIRE)-- Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that its Lixoft division, a leading provider of population PKPD modeling solutions for pharmacometricians and biostatisticians, has released an update to version 2021R1 of its MonolixSuite platform.

Key advancements include:

• A new bioequivalence module in PKanalix with a graphical user interface (GUI) featuring:
  • Management of replicated crossover, nonreplicated crossover, and parallel designs
  • Very flexible interface with easy manipulation and interactive plots
• New R functions to ease reporting
• A new parent-metabolite library
• New features in Monolix (e.g., generalized automatic initialization)
• New model editor
• Faster calculation in case of interoccasion variability and parent-metabolite models
• More flexible plots (e.g., VPC since last dose, trends for observations, and log scales)
• Improved performance for data, libraries, and algorithms

The continued improvements to the MonolixSuite platform allow for a complete modeling and simulation workflow from data analysis and non-compartmental analysis to population modeling and simulation with fully interoperable applications. It provides users with a fast, uncomplicated, and powerful suite of applications for pharmacometrics analysis. Specifically, the bioequivalence module in PKanalix is a robust and flexible platform for bioequivalence, DDI, and food interaction studies with an easy-to-use interface.

Jonathan Chauvin, president of the Lixoft division, said: “This is a significant breakthrough for the platform, especially for the bioequivalence and the new Monolix features. These changes are a combination of features requested by industry and academic scientists and our own beliefs that extend the power of the MonolixSuite in important ways for modeling and simulation of both preclinical and clinical data. It represents our vision to design products with advanced user experience, statistical methods, and computational performance.”

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.

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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Simulations Plus Investor Relations

Ms. Renee Bouche

661-723-7723

renee.bouche@simulations-plus.com

Hayden IR

Mr. Brian Siegel

346-396-8696

brian@haydenir.com

Source: Simulations Plus, Inc.