LANCASTER, Calif. - Simulations Plus , Inc. (NASDAQ:SLP), a provider of modeling and simulation software for the pharmaceutical industry, has secured a grant from the U.S. Food and Drug Administration (FDA) to enhance and validate a dermal physiologically based biopharmaceutics/pharmacokinetics (PBBM/PBPK) model.
This initiative, in collaboration with the University of Bath and other academic partners, aims to improve the development and regulatory evaluation of topical drugs.
The grant will support the integration of in vitro study data into the GastroPlus® platform's Transdermal Compartmental Absorption and Transit (TCAT™) model. The enhanced model is expected to provide a more reliable alternative to in vivo studies for establishing bioequivalence (BE) in topical products.
The University of Bath's Skin Biosciences group, led by Professor M. Begoña Delgado-Charro and Professor Richard Guy, along with the Colorado School of Mines and the University of Reading, will generate the necessary in vitro data. The scientific team at Simulations Plus will then use these data to improve and validate the TCAT™ model, incorporating additional pathophysiology information for skin disease populations.
Dr. Maxime Le Merdy, Associate Director of PBPK Solutions at Simulations Plus and lead investigator for the grant, expressed enthusiasm about the collaboration's potential to advance the accuracy of topical drug performance predictions and streamline regulatory decisions.
The project's objective is to bridge the gap between in vitro and in vivo data, facilitating the creation of innovative models for drug development. The FDA and its scientific and program staff will actively collaborate with the academic and industry partners to achieve this goal.
Funding for the collaboration comes from the FDA through grant award 1U01FD007957-01. The views expressed in the press release do not necessarily reflect the official policies of the Department of Health and Human Services, nor imply government endorsement.
Simulations Plus has been serving clients globally for over 25 years, offering software and consulting services that span across various modeling approaches in drug discovery and development. This grant represents another step in the company's commitment to supporting safer healthcare solutions through advanced modeling technologies.
The information in this article is based on a press release statement.
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