Simulations Plus and the University of Florida Awarded New FDA Contract to Support Development and Regulatory Assessment of Inhaled Products

Simulations Plus and the University of Florida Awarded New FDA Contract to Support Development and Regulatory Assessment of Inhaled Products

Division: PBPK

Collaboration combines novel in vitro experimental methods and mechanistic modeling to accelerate development of orally inhaled drug products (OIDPs) and propose alternative approaches for bioequivalence

Simulations Plus Successfully Delivers FDA-Funded Project

Simulations Plus Successfully Delivers FDA-Funded Project

Software: Monolix®

Collaboration with the US FDA and Center for Research on Complex Generics to Establish the Suitability of Model-Integrated Evidence to Demonstrate Bioequivalence for Long-Acting Injectables