Opportunity Information: Apply for RFA FD 21 012
The government grant opportunity titled "Physiologically Based Pharmacokinetic (PBPK) Models of Oral Absorption to Simulate the Results of Bioequivalence Studies (U01)" invites research proposals focused on enhancing the use of PBPK models. These models play a crucial role in understanding how drug absorption and systemic distribution occur, allowing researchers to simulate these processes without needing to conduct in vivo studies. By integrating product characteristics and physiological variability among individuals, PBPK models have shown potential in aiding generic drug development and informing regulatory decisions. This grant aims to expand the application of oral PBPK models to address new challenges in the generic drug sector, specifically to simulate bioequivalence studies across different scenarios.
Apply for RFA FD 21 012
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, food and nutrition, science and technology and other research and development sector is offering a public funding opportunity titled "Physiologically Based Pharmacokinetic (PBPK) Models of Oral Absorption to Simulate the Results of Bioequivalence Studies (U01) Clinical Trials Optional" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Jan 07, 2021.
- Applicants must submit their applications by Mar 15, 2021. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2025.)
- Each selected applicant is eligible to receive up to $600,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Apply for RFA FD 21 012
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Applicants who have applied for this opportunity (RFA FD 21 012) also looked into and applied for these:
| Funding Opportunity |
|---|
| Development of a model selection method for population pharmacokinetics analysis by deep-learning based reinforcement learning (U01) Clinical Trials Not Allowed Apply for RFA FD 21 027 Funding Number: RFA FD 21 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $250,000 |
| Quantify the expression of metabolizing enzymes and transporter proteins in lung, eye and skin tissue in relevant animal models and humans (U01) Clinical Trial Not Allowed Apply for RFA FD 21 018 Funding Number: RFA FD 21 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $850,000 |
| Development of Advanced Analytical Methods for the Characterization of Iron Carbohydrate Complex - Ferric Derisomaltose (U01) Clinical Trials Not Allowed Apply for RFA FD 21 016 Funding Number: RFA FD 21 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $600,000 |
| Renewal - Elucidating the Sensorial and Functional Characteristics of Compositionally Different and Differently Aged Topical Formulations (U01) Clinical Trial Required Apply for RFA FD 21 021 Funding Number: RFA FD 21 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $500,000 |
| Dermal Physiologically-based Pharmacokinetic (PBPK) Models Accounting for the Absorption and Evaporation of Vehicle/Co-solvent following the Application of Generic Dermatological Products (U01) Apply for RFA FD 21 019 Funding Number: RFA FD 21 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $500,000 |
| Drug Development Tools Research Grants (U01) Clinical Trial Optional Apply for PAR 21 178 Funding Number: PAR 21 178 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $250,000 |
| Impulse Oscillometry Endpoint Sensitivity to Regional Lung Function Changes using Computational Fluid Dynamics (CFD) (U01) Clinical Trial Required Apply for RFA FD 21 020 Funding Number: RFA FD 21 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Expanding the opioids system modeling efforts to more comprehensively address fentanyl, stimulants use, polysubstance use and associated outcomes.(U01) Clinical Trials Not Allowed Apply for RFA FD 21 022 Funding Number: RFA FD 21 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $1,250,000 |
| Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) (U01) Clinical Trials Not Allowed Apply for RFA FD 21 026 Funding Number: RFA FD 21 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $600,000 |
| SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots) Public-Private Partnership (PPP) under PASI (Pediatric Anesthesia Safety Initiative) (U01) Clinical Trials Not Allowed Apply for RFA FD 21 025 Funding Number: RFA FD 21 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $450,000 |
| Pediatric and Perinatal COVID-19 Registry (U18) Clinical Trials Optional Apply for RFA FD 21 035 Funding Number: RFA FD 21 035 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
| Innovation Award: COVID-19 and Health Equity (U01) Clinical Trials Optional Apply for RFA FD 22 003 Funding Number: RFA FD 22 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Deconstruction of data and standards to support harmonization and interoperability with real world data for clinical research and regulatory submissions. (U01 Clinical Trial Not Allowed) Apply for RFA FD 22 022 Funding Number: RFA FD 22 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $350,000 |
| Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24) Clinical Trials Not Allowed Apply for RFA FD 23 002 Funding Number: RFA FD 23 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $400,000 |
| Centers of Excellence in Regulatory Science and Innovation (CERSI) Apply for RFA FD 23 004 Funding Number: RFA FD 23 004 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
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