The University of Connecticut (UConn) was awarded a $1,310,263 cost-no-fee definitive contract by the Food and Drug Administration (FDA) to enhance and validate in vitro-in vivo correlation (IVIVC) methods for long-acting injectable drug products to accelerate their generic development. The contract is part of the FDA's Broad Agency Announcement for Advanced Regulatory Science, which solicits research and development proposals across various areas to modernize regulatory science and support the agency's mission.
As a subcontractor under this contract, Simulations Plus Inc. will perform activities such as establishing preclinical IVIVC models, enhancing physiologically-based pharmacokinetic (PBPK) models, and validating IVIVC predictions for new formulations of long-acting injectable drug products. This work leverages Simulations Plus' expertise in pharmaceutical modeling and simulation software used for drug discovery, development, and regulatory assessment. The contract does not have a set-aside designation.
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