Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional
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Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional: The purpose of this funding opportunity is to examine the utility of an in vitro simulated gastrointestinal (GI) dissolution model for the assessment of in vitro performance of amorphous solid dispersion (ASD) drug products under different clinically relevant conditions. The goal is to develop and validate the in vitro mechanistic methodology to provide an improved understanding of impact of food and acid reducing agents on the absorption for test and reference listed drug (RLD) drug products, taking into consideration their potentially different formulations and manufacturing. The bio predictive in vitro mechanistic methodology is intended to correlate the in vitro observations to in vivo outcomes, help define types of in vivo bioequivalence (BE) studies needed for ASD drug products, and inform regulatory decision-making related to mitigating the risk of potential failure modes for therapeutic equivalence for high-risk generic oral drug products.
Federal Grant Title: | Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional |
Federal Agency Name: | Food and Drug Administration (HHS-FDA) |
Grant Categories: | Agriculture Consumer Protection Food and Nutrition |
Type of Opportunity: | Discretionary |
Funding Opportunity Number: | RFA-FD-24-009 |
Type of Funding: | Cooperative Agreement |
CFDA Numbers: | 93.103 |
CFDA Descriptions: | Information not provided |
Current Application Deadline: | March 31st, 2024 |
Original Application Deadline: | March 31st, 2024 |
Posted Date: | January 15th, 2024 |
Creation Date: | January 15th, 2024 |
Archive Date: | April 30th, 2024 |
Total Program Funding: | $250,000 |
Maximum Federal Grant Award: | $250,000 |
Minimum Federal Grant Award: | |
Expected Number of Awards: | 2 |
Cost Sharing or Matching: | No |
Last Updated: | January 15th, 2024 |
- Applicants Eligible for this Grant
- 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 - Unrestricted (i.e., open to any type of entity below), subject to any clarification in text field entitled "Additional Information on Eligibility"
- Grant Announcement Contact
- Terrin Brown
Grantor
Phone 2404027610
[email protected] - Similar Government Grants
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