The CDER is offering a grant to research predictive in vitro methods for characterizing product performance, focusing on the case study of Furosemide. Previous studies showed higher dissolution of Furosemide in media containing milk and baby formula. This project aims to further explore methodologies to characterize Furosemide dissolution in various media and assess their ability to predict in vivo performance of this poorly soluble and permeable drug. Researchers will focus on BCS Class IV drugs and aim to enhance understanding of product performance. Grant applications are open until July 15, 2014.
Opportunity ID: 257068
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-14-080 |
| Funding Opportunity Title: | Predictive in vitro Methods for Characterizing Product Performance, Case Study: Furosemide (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Consumer Protection Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration_Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jun 09, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jul 15, 2014 |
| Current Closing Date for Applications: | Jul 15, 2014 |
| Archive Date: | Aug 14, 2014 |
| Estimated Total Program Funding: | $100,000 |
| Award Ceiling: | $100,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Public housing authorities/Indian housing authorities Private institutions of higher education Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) State governments Native American tribal governments (Federally recognized) City or township governments Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses |
| Additional Information on Eligibility: | Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
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 explore additional methodology to characterize dissolution of furosemide (the model drug) in media containing milk, baby formula and Ensure Plus™. The suitability of methods including 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 explored and determined. |
| Link to Additional Information: | Full Announcement RFA-FD-14-080 |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Lisa Ko
Grants Management Specialist Email:lisa.ko@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 257068 Other Supporting Documents-SF424 RR Application Guide 1 -> SF424_RR_Guide_General_Adobe_VerC.pdf
Packages
| Agency Contact Information: | Lisa Ko Grants Management Specialist Email: lisa.ko@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 | PKG00198544 | Jun 13, 2014 | Jul 15, 2014 | View |
Package 1
Mandatory forms
257068 RR_SF424_2_0-2.0.pdf
257068 PHS398_ResearchPlan_2_0-2.0.pdf
257068 PHS398_CoverPageSupplement_2_0-2.0.pdf
257068 RR_Budget_1_3-1.3.pdf
257068 RR_KeyPersonExpanded_2_0-2.0.pdf
257068 RR_OtherProjectInfo_1_3-1.3.pdf
257068 PerformanceSite_2_0-2.0.pdf
Optional forms
257068 PlannedReport-1.0.pdf
257068 PHS398_CumulativeInclusionReport-1.0.pdf
257068 RR_SubawardBudget30_1_3-1.3.pdf
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