Business
Simulations Plus Receives New FDA Grant Award
Collaboration with regulatory, industry, and academic partners will support and accelerate the development and validation of workflows to conduct virtual
About this update from Simulations Plus, Inc.
[{"type":"text","content":"\nCollaboration with regulatory, industry, and academic partners will support and accelerate the development and validation of workflows to conduct virtual bioequivalence studies\n\n\n LANCASTER, Calif.--(BUSINESS WIRE)--\nSimulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced it has been awarded a new funded grant from the U.S. Food and Drug Administration (FDA). The grant will be used to validate and define best practices for physiologically based biopharmaceutics/pharmacokinetics (PBBM/PBPK) modeling workflows to simulate virtual bioequivalence (VBE) studies in support of regulatory biowaivers.\n\n\nThe scientific team at Simulations Plus, with partners from the FDA, industry, and academia, will apply public and proprietary datasets to validate the ability of GastroPlus® and other software to predict inter- and intra-subject variability when performing virtual population simulations. Enhancements to the existing VBE simulation engine within GastroPlus will be implemented, and best practices will be defined for VBE evaluation using mechanistic PBBM/PBPK approaches. The goal of this work is to inform regulatory decisions and guide innovator and generic drug developers in the design of VBE studies for distinct types of drug products.\n\n\nDr. Frederico Martins, Principal Scientist and LATAM Scientific Lead, PBPK Solutions, and Principal Investigator for this grant, said: “At the recent PBBM/PBPK workshop sponsored by the University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) and the FDA, it became clear that regulatory agencies worldwide are actively promoting the increased adoption of VBE approaches in numerous ways. The many case studies presented at the workshop, nearly all of which utilized GastroPlus simulations, firmly reinforced GastroPlus as the leading software platform for drug product development. With this new award, we are poised to shape industry best practices and define innovative workflows for leveraging in vitro systems and in silico models to further reduce regulatory burden and minimize the need for human studies.”\n\n\nFDA scientific and program staff will actively collaborate with Simulations Plus and others from industry and academia. D...