Simulations Plus partners with Lonza, FDA on predictive modeling for oral drug products

• Simulations Plus entered a funded research collaboration with Lonza, U.S. FDA to develop mechanistic predictive frameworks for amorphous solid dispersion oral drug products.
• Project targets improved prediction of in vivo performance, including food effects, using advanced in vitro dissolution systems paired with physiologically based biopharmaceutics modeling.
• Lonza will run experimental dissolution testing under fasted, fed, elevated gastric pH conditions using Controlled Transfer Dissolution.
• Simulations Plus will build IVIVE frameworks using DDDPlus, GastroPlus to support virtual bioequivalence assessments.
• Collaboration aims to reduce reliance on some clinical bioequivalence studies while supporting regulatory decision-making for complex oral formulations.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Simulations Plus Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 202604210755BIZWIRE_USPR_____20260421_BW564555) on April 21, 2026, and is solely responsible for the information contained therein.