The CDER is offering a grant to study predictive methods for characterizing furosemide performance in pediatric patients. This research aims to collect in vivo data on furosemide administered with milk, baby formula, and Ensure Plus to healthy adults. The project will assess the suitability of in vitro methods using different dissolution media for predicting the in vivo performance of furosemide, a BCS Class IV drug. The deadline for applications is August 15, 2013.
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:: | |
| Category of Funding Activity:: | Consumer Protection |
| Category Explanation:: | |
| Expected Number of Awards:: | 3 |
| Assistance Listings Number(s):: | 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 |
| Current Closing Date for Applications:: | Aug 15, 2013 |
| 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:: | |
| Grantor Contact Information:: | If you have difficulty accessing the full announcement electronically, please contact: |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Synopsis 1 |
Package Status
Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:
Package No: 1
| Assistance Listings: | 93.103 |
| Competition ID: | |
| Competition Title: | |
| Opportunity Package ID: | PKG00181336 |
| Opening Date: | Aug 01, 2013 |
| Closing Date: | Aug 16, 2013 |
| Agency Contact Information:: | Oluyemisi (Yemisi) Akinneye |
| Who Can Apply:: | Organization Applicants |
| mendatory_forms |
SF424 (R & R) [V1.2] Project/Performance Site Location(s) [V1.4] Research And Related Other Project Information [V1.3] Research And Related Senior/Key Person Profile (Expanded) [V1.2] Research & Related Budget [V1.1] PHS 398 Cover Page Supplement [V1.4] PHS 398 Research Plan [V1.3] PHS 398 Checklist [V1.3] |
| optional_forms |
R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2] PHS Cover Letter [V1.2] |
Packages
| Assistance Listings | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions | Who Can Apply: | |
|---|---|---|---|---|---|---|---|---|
| 93.103 | PKG00181336 | Aug 01, 2013 | Aug 16, 2013 | View | Oluyemisi (Yemisi) Akinneye | Organization Applicants |