Simulations Plus Releases MembranePlus 3.0

Rhea-AI Summary

Simulations Plus (NASDAQ: SLP) has launched MembranePlus™ 3.0, enhancing in vitro-in vivo extrapolation (IVIVE) for transdermal product analysis. Key features include new models for in vitro penetration and release tests, expanded membrane transport parameters, and improved simulation performance. The update aims to provide insights for formulation strategies, reducing the need for animal testing. Senior Scientist Dr. Jessica Spires noted the product's integration with GastroPlus® to benefit researchers in predicting topical administration outcomes.

Positive

• Launch of MembranePlus™ 3.0 enhances IVIVE for transdermal products.
• New models for in vitro penetration and release improve absorption analysis.
• Expanded parameters enhance predictions for small and peptide molecules.
• Integration with GastroPlus® offers innovative prediction capabilities.

Negative

• None.

New functionality for transdermal products creates a state-of-the-art IVIVE methodology in combination with the GastroPlus TCAT platform

LANCASTER, Calif.--(BUSINESS WIRE)-- Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today announced it has released MembranePlus™ 3.0 to drive advances to in vitro-in vivo extrapolation (IVIVE) for permeability, hepatocyte, skin penetration, and release assay systems.

Key enhancements in this new version include:

• New models of in vitro penetration (IVPT) and release (IVRT) tests for transdermal formulations for novel analysis of absorption and dissolution kinetics
• Expanded membrane transport model parameters for improved predictions of permeability coefficients for both small and peptide molecules
• Improved data handling and simulation performance

Dr. Jessica Spires, Senior Scientist II and lead programmer on MembranePlus, said: “Through collaborations with the FDA and industry partners over the past several years, we have applied original data sets to design and validate models for in vitro dermal product evaluation, including skin penetration and release tests. These extensions now in MembranePlus fit seamlessly with recent improvements to the GastroPlus^® transdermal compartmental absorption and transit (TCAT™) platform, giving researchers a unique and innovative simulation engine to predict exposure following topical administration of numerous formulations dosed in animals and humans. This amplified integration will be appreciated by all markets we support by providing greater insight into formulation strategies, serving as an alternative to animal testing for safety evaluation, and establishing a future foundation for virtual bioequivalence (VBE) assessment.”

“Our talented team has taken expert input from our collaboration partners to thoughtfully design the intuitive, one-of-a-kind connections between MembranePlus and GastroPlus,” added Dr. Haiying Zhou, Director of Simulation Technologies. “Developing computational models for more studies and covering a wider chemical space with our system parameters further reinforces MembranePlus as the preeminent modeling and simulation analysis tool for IVIVE of absorption, clearance, and distribution processes. We look forward to sharing these exciting developments with all users to advance model-informed drug development.”

About Simulations Plus

Serving clients worldwide for 25 years, Simulations Plus is a leading provider in the biosimulation market providing 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, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on Twitter | LinkedIn.

Environmental, Social, and Governance (ESG)

We focus our Environmental, Social, and Governance (ESG) efforts where we can have the most positive impact. To learn more about our latest initiatives and priorities, please visit our website to read our 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220310005418/en/

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.

FAQ

What is the significance of MembranePlus™ 3.0 for Simulations Plus (SLP)?

MembranePlus™ 3.0 enhances IVIVE methodologies for transdermal products, providing improved analysis and predictions for researchers.

What new features does MembranePlus™ 3.0 include?

Key features include new models for in vitro penetration, expanded membrane transport parameters, and enhanced simulation performance.

How does MembranePlus™ 3.0 benefit researchers in drug development?

It offers insights into formulation strategies and serves as an alternative to animal testing for product safety evaluations.

How does Simulations Plus (SLP) ensure collaboration in the development of MembranePlus™ 3.0?

The development was guided by expert input from industry partners and collaborations with the FDA.

When was MembranePlus™ 3.0 released by Simulations Plus (SLP)?

MembranePlus™ 3.0 was announced in a press release dated March 10, 2022.