FDA grants Simulations Plus to use PBPK to expand mechanistic modeling for LAI

Simulations Plus (SLP) announced that it has been awarded a newly funded grant from the U.S. Food and Drug Administration FDA to use physiologically based pharmacokinetic PBPK approaches in GastroPlus to build and validate mechanistic in vitro-in vivo correlations IVIVCs for long-acting injectable LAI technologies through a joint proposal with the University of Connecticut’s School of Pharmacy, Department of Pharmaceutical Sciences. This project aims to use the GastroPlus PBPK platform to investigate the intricate relationship between LAI formulation critical quality attributes CQAs and physiological factors at the injection site to accurately predict in vivo drug release and absorption. Dr. Diane Burgess, Board of Trustees Distinguished Professor of Pharmaceutics and Pfizer Distinguished Endowed Chair of Pharmaceutical Technology at the University of Connecticut and her lab will generate in vitro and in vivo data for marketed LAI suspension products using novel discriminatory systems. The scientific team at Simulations Plus will use this data, along with additional inputs from research collaborators, to develop PBPK models and apply them to validate mechanistic IVIVCs. This effort is expected to lay the groundwork for a practical alternative to in vivo studies in establishing bioequivalence BE for additional LAI product technologies.

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