Building on previous CDER research indicating higher furosemide dissolution in milk and baby formula media, this department is offering this grant to advance the characterization of product performance, especially for pediatric patients. This grant’s core purpose is to collect vital in vivo data by administering furosemide, a BCS Class IV drug, with milk, baby formula, and Ensure Plus™ to healthy adult subjects. The collected in vivo data will then be used to determine the suitability of the earlier developed in vitro methods, which incorporated these specific dissolution media, for accurately predicting the real-world in vivo performance of furosemide. This validation is crucial for developing robust predictive methods for pediatric formulations.
Opportunity ID: 237973
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA–FD-13-035 |
| Funding Opportunity Title: | Predictive Methods for Characterizing Product Performance in Pediatric Patients, Case Study: Furosemide |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | CategoryExplanation |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 3 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jul 19, 2013 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Aug 15, 2013 The application receipt/due date is August 15, 2013 by 11:59PM Eastern time. |
| Current Closing Date for Applications: | Aug 15, 2013 The application receipt/due date is August 15, 2013 by 11:59PM Eastern time. |
| Archive Date: | Sep 14, 2013 |
| Estimated Total Program Funding: | $250,000 |
| Award Ceiling: | $100,000 |
| Award Floor: | $0 |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | This project follows after earlier CDER research projects in which in vitro furosemide dissolution and/or solubility data were collected in various dissolution media such as simulated gastric and intestinal fluids. In two different studies with different approaches and dissolution testing apparatus, furosemide dissolution was higher in medium containing milk and baby formula than that in standard buffer medium.
This research project will allow collecting in vivo data when furosemide (the model drug) will be given with milk, baby formula and Ensure Plus to healthy adults. The suitability of the in vitro methods using dissolution media containing milk, baby formula and Ensure Plus for predicting in vivo performance of furosemide (a poorly soluble and poorly permeable drug), classified as BCS (Biopharmaceutic Classification System) Class IV drug will be determined. |
| Link to Additional Information: | NIH Guide for Grants and Contracts |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Oluyemisi (Yemisi) Akinneye
Grants Management Specialist Phone 3018270079 Email:Oluyemisi.Akinneye@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | Oluyemisi (Yemisi) Akinneye Grants Management Specialist Phone 3018270079 Email: Oluyemisi.Akinneye@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | PKG00181336 | Aug 01, 2013 | Aug 16, 2013 | View |
Package 1
Mandatory forms
237973 RR_SF424_1_2-1.2.pdf
237973 PerformanceSite_1_4-1.4.pdf
237973 RR_OtherProjectInfo_1_3-1.3.pdf
237973 RR_KeyPersonExpanded_1_2-1.2.pdf
237973 RR_Budget-1.1.pdf
237973 PHS398_CoverPageSupplement_1_4-1.4.pdf
237973 PHS398_ResearchPlan_1_3-1.3.pdf
237973 PHS398_Checklist_1_3-1.3.pdf
Optional forms
237973 RR_SubawardBudget30-1.2.pdf
237973 PHS_CoverLetter_1_2-1.2.pdf
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