FDA awards Simulations Plus a grant through proposal with University of Bath

Simulations Plus announced that, through a joint proposal with the University of Bath’s Department of Life Sciences and other university partners, it has been awarded a new funded grant from the U.S. Food and Drug Administration FDA . The grant will be used to expand and validate a multi-functional, multi-purpose physiologically based biopharmaceutics/pharmacokinetics or PBBM/PBPK, modeling solution for topical products within the GastroPlus platform that can inform regulatory decisions for both innovator and generic products… “Collaborating with the University of Bath and other partners on this groundbreaking FDA grant is a remarkable opportunity. Our joint efforts are set to deliver an advanced, rigorously validated, and mechanistic dermal PBBM/PBPK model that leverages novel in vitro experimental designs,” said Dr. Maxime Le Merdy, Associate Director, Research & Collaborations of PBPK Solutions, and lead investigator for this grant for Simulations Plus. “This innovation promises to revolutionize the prediction accuracy of topical drug product performance. By doing so, we aim to significantly expedite the regulatory decision-making process, ultimately benefiting patients and the pharmaceutical industry.” ..Funding for this collaboration is made possible by the Food and Drug Administration through grant award 1U01FD007957-01. Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.