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Simulations Plus Broadens FDA Use of ADMET Predictor® by Securing New Licenses for the Cosmetics Regulatory Science Division

Simulations Plus Licenses ADMET Predictor® to FDA for Cosmetic Safety Assessments

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE) – Simulations Plus, Inc. (Nasdaq: SLP), a leader in AI-accelerated drug development, has announced that the U.S. Food and Drug Administration (FDA) has licensed its ADMET Predictor® software to enhance modern cosmetic safety assessments through integrated exposure and toxicity modeling.

The ADMET Predictor platform employs advanced AI and machine learning technologies, allowing researchers to predict endpoint properties and systemic exposure in both animals and humans quickly. This partnership signifies the FDA’s acknowledgment of the critical role predictive modeling plays in regulatory research.

Key Features of ADMET Predictor:

  • High-throughput pharmacokinetic modeling: Allows for the rapid assessment of potential exposure and hazards associated with cosmetic products.
  • Support for New Approach Methodologies (NAMs): Aligns with FDA’s initiatives for science-based, animal-free safety assessments.

Simulations Plus is also partnering with the International Collaboration on Cosmetics Safety (ICCS) to further evaluate animal-free safety assessment approaches in 2024.

Shawn O’Connor, CEO of Simulations Plus, emphasized the trust placed in ADMET Predictor by global researchers, stating, “The FDA’s adoption expands our relationship with one of the world’s leading regulatory organizations.”

About Simulations Plus, Inc.

Simulations Plus is dedicated to advancing drug development through innovative software solutions. For more information, visit www.simulations-plus.com.

Forward-Looking Statements

This press release contains forward-looking statements involving risks and uncertainties regarding the company’s future performance and the anticipated effects of its software solutions.

Contact Information

Investor Relations Contact:
Lisa Fortuna
Financial Profiles
310-622-8251
slp@finprofiles.com

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