Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
Agency: Food and Drug Administration
Assistance Listings: 93.103 -- Food and Drug Administration Research
Description
The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products.
Eligibility
Eligible applicants
Nonprofit
- Other Native American tribal organizations
- Nonprofits non-higher education with 501(c)(3)
- Nonprofits non-higher education without 501(c)(3)
Government
- Special district governments
- Federally recognized Native American tribal governments
- County governments
- Public and Indian housing authorities
- State governments
- City or township governments
Business
- For-profit organizations other than small businesses
- Small businesses
Miscellaneous
- Unrestricted
- Other
Education
- Independent school districts
- Private institutions of higher education
- Public and state institutions of higher education
Additional information
Grantor contact information
Description
terrin.brown@fda.hhs.gov
Documents
No documents are currently available.
Link to additional information
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Forecasted
Estimated Post Date:
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Estimated Application Due Date:
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Estimated Due Date Description:
Not available
Estimated Award Date:
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Estimated Project Start Date:
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Fiscal Year:
2024
Award
$--
Program Funding
1
Expected awards
$250,000
Award Minimum
$250,000
Award Maximum
Funding opportunity number:
FOR-FD-24-004
Cost sharing or matching requirement:
Funding instrument type:
Cooperative agreement
Opportunity Category:
Discretionary
Opportunity Category Explanation:
Category of Funding Activity:
Consumer protection
Food and nutrition
Agriculture
Category Explanation:
History
Version:
3
Forecast posted date:
November 24, 2023
Archive date:
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