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Simulations Plus and Partners Awarded New FDA Grant to Validate In Vitro-In Vivo Extrapolation Methods for Complex Formulations
Collaboration goal to develop alternative methods to assess clinical performance of product variants under different conditions LANCASTER, Calif.--(BUSINESS
About this update from Simulations Plus, Inc.
[{"type":"text","content":"\nCollaboration goal to develop alternative methods to assess clinical performance of product variants under different conditions\n\n LANCASTER, Calif.--(BUSINESS WIRE)--\nSimulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus”), a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, today announced a newly funded grant from the U.S. Food and Drug Administration (FDA), secured in partnership with the University of Strathclyde and InnoGI Technologies. The project is expected to improve the understanding of amorphous solid dispersion (ASD) formulations in different conditions and predict the impact of food and pH-dependent drug-drug interactions (DDIs) through the combination of novel in vitro testing and mechanistic modeling and simulation.\n\nFor this award, Professor Hannah Batchelor, through her lab at the University of Strathclyde, will analyze ASD drug products and their respective formulation variants. InnoGI Technologies will then test the different ASD formulations under fasted, fed, and higher gastric pH conditions utilizing the tiny-TIMsg, part of the SurroGUT™ Platform, in vitro system. Next, physiologically based pharmacokinetic (PBPK) models will be developed in the GastroPlus® platform to link in vitro dissolution with in vivo pharmacokinetic data and develop in vitro-in vivo extrapolations (IVIVEs). Finally, virtual bioequivalence (VBE) trial simulations will be conducted in GastroPlus to assess the clinical performance of ASD formulation variants to validate the approaches. The resulting outcomes are anticipated to help speed up formulation adjustments, reduce costs, and accelerate time-to-market for both innovator and generic ASD products.\n\n“We are delighted to be at the forefront of this important research, which has the potential to significantly advance PBPK science and revolutionize how we predict drug product performance,” said Dr. Maxime Le Merdy, Director of PBPK Collaborations at Simulations Plus and principal investigator for this grant. “Developing a novel IVIVE methodology for ASD drug products will play a crucial role in optimizing formulation development, fine-tuning process parameters, and supporting bioequivalence assessments by offering key insights into the factors that impact in vivo performance.”\n...