Simulations Plus Inc. (NASDAQ: SLP) announced a funded research collaboration with Lonza Group AG and the U.S. Food and Drug Administration to develop a predictive framework for assessing amorphous solid dispersion drug products.

The collaboration aims to integrate advanced in vitro systems with mechanistic modeling to improve prediction of in vivo performance for complex oral formulations. Amorphous solid dispersions are oral drug delivery systems whose performance is influenced by factors including food intake, gastric pH, formulation composition, and manufacturing processes.

Current regulatory approaches often require multiple clinical bioequivalence studies. The collaboration will evaluate whether advanced in vitro dissolution systems combined with physiologically based biopharmaceutics modeling can reliably predict key in vivo outcomes, including food effects and elevated gastric pH conditions.

Lonza will lead experimental work, including in vitro dissolution testing under fasted, fed, and elevated gastric pH conditions using systems such as Controlled Transfer Dissolution. The company will also handle characterization and manufacturing of formulation variants.

Simulations Plus will develop and validate in vitro-in vivo extrapolation frameworks using its DDDPlus and GastroPlus platforms. The company will translate experimental data into predictions of in vivo pharmacokinetics and support virtual bioequivalence assessments.

"Complex oral formulations such as amorphous solid dispersions present significant scientific and regulatory challenges due to their sensitivity to physiological and manufacturing variables," said Dr. Viera Lukacova, Chief Scientific Officer of Simulations Plus.

The work is supported through FDA funding and includes engagement with FDA scientists to align with regulatory priorities for model-informed drug development and bioequivalence assessment for complex products.