Lixoft Adds New Bioequivalence Module in MonolixSuite® Version 2021R1

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.

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