TABLE 1.
Grants and contracts including mechanistic modeling and simulation approaches (including PBPK and CFD) for ophthalmic, nasal, injectable, buccal/sublingual, and female reproductive drug products awarded during GDUFA I and II regulatory research and science programs.
| Area | Title | Duration | Institute | Award no. |
|---|---|---|---|---|
| Ophthalmic | Development and validation of a PBPK/PD modeling strategy for ophthalmic drug products to support translation from preclinical species to humans | 2020–2023 | Simulations Plus | 1U01FD006927 |
| Computational Biology (Cobi) tools as a framework for PBPK/PD model extrapolation from rabbit to human for ophthalmic drug products | 2020–2023 | CFD Research Corporation | 1U01FD006929 | |
| An integrated multiscale‐multiphysics modeling framework for evaluation of generic ophthalmic drug products | 2018–2022 | CFD Research Corporation | HHSF223201810151C | |
| Simulation plus ophthalmic ointment implementation | 2018–2019 | Simulations Plus | HHSF223201810255P | |
| PBPK modeling and simulation for ocular dosage forms | 2014–2018 | Simulations Plus | 1U01FD005211 | |
| An integrated multiscale‐multiphysics modeling and simulation of ocular drug delivery with whole‐body PK response | 2014–2018 | CFD Research Corporation | 1U01FD005219 | |
| Nasal | Development of hybrid CFD‐PBPK models for absorption of intranasal corticosteroids | 2014–2018 | Applied Research Associates, Inc. | 1U01FD005201 |
| Nasal mucociliary clearance affecting local drug‐absorption in subject‐specific geometries | 2018–2021 | North Carolina State University | 1U01FD006537 | |
| Evaluating relationships between in vitro nasal spray characterization test metrics for bioequivalence and nasal deposition in silico and in vitro | 2018–2021 | Virginia Commonwealth University | HHSF223201810144C | |
| Modifications and improvements to hybrid CFD‐PBPK models for prediction of nasal corticosteroid deposition, absorption, and bioavailability | 2019–2022 | Applied Research Associates, Inc. | 75F40119C10079 | |
| Evaluation of current approaches used to establish bioequivalence of nasal sprays for local action in children | 2020–2023 | Virginia Commonwealth University | 75F40120C00172 | |
| LAI and complex injectables | MIDD approach to identify critical quality attributes and specifications for generic nanotechnology products | 2019–2023 | Institute of Quantitative Systems Pharmacology | 75F40119C10139 |
| Enhancement and validation of IVIVC method for long‐acting injectable drug products to accelerate their generic development | 2021–2024 | University of Connecticut | 75F40121C00133 | |
| Female reproductive | Physiologically based model of the female reproductive tract: vaginal and intrauterine delivery components | 2018–2024 | State University of New York at Buffalo | HHSF223201810188C |
| Buccal/sublingual products | Robust in vitro/in silico model to accelerate generic drug product development for the oral cavity route of administration | 2020–2023 | University of Health Sciences and Pharmacy in St. Louis | 75F40120C00150 |
Abbreviations: CFD, computational fluid dynamics; GDUFA, Generic Drug User Fee Amendments; IVIVC, in vitro in vivo correlation; LAI, long‐acting injectable; MIDD, model‐informed drug development; PBPK, physiologically‐based pharmacokinetic; PD, pharmacodynamic; PK, pharmacokinetic.