- Simulations Plus, Lonza, and the U.S. FDA have entered a funded collaboration to develop a predictive framework for amorphous solid dispersion (ASD) drug products.
- The initiative aims to integrate in vitro testing and mechanistic modeling to improve prediction of in vivo drug performance and support regulatory decision-making.
Simulations Plus, Inc. has announced a funded research collaboration with Lonza Group AG and the U.S. Food and Drug Administration to develop and validate a mechanistic framework for predicting the in vivo performance of amorphous solid dispersion (ASD) drug products. The collaboration focuses on improving model-informed drug development approaches for complex oral formulations.
The project brings together expertise in experimental testing, computational modeling, and regulatory science. Lonza, a CDMO, will lead in vitro dissolution studies under varying physiological conditions, including fasted, fed, and elevated gastric pH environments. Simulations Plus will develop and validate in vitro–in vivo extrapolation (IVIVE) models using its software platforms to predict pharmacokinetics and support virtual bioequivalence assessments.
The collaboration addresses challenges associated with ASD formulations, whose performance can be affected by multiple physiological and manufacturing variables. Current regulatory approaches often require multiple clinical bioequivalence studies. The partners aim to evaluate whether advanced in vitro systems combined with mechanistic modeling can reduce reliance on such studies while maintaining regulatory standards.
“Through this funded collaboration, we aim to integrate advanced in vitro systems with mechanistic modeling to improve prediction of in vivo performance, support regulatory decision-making, and enable more efficient development pathways for these high-impact therapies that deliver faster dissolution and more drug absorption.”
Dr. Viera Lukacova, Chief Scientific Officer of Simulations Plus
The work is supported in part by FDA funding and includes ongoing engagement with regulatory scientists. The companies stated that the collaboration will contribute to the development of validated, science-based approaches for assessing complex oral drug products and may inform future regulatory practices.
