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Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
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.
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.
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $250,000
Office: Food and Drug Administration
Estimated Funding: $250,000
Who's Eligible
Obtain Full Opportunity Text:
NSF Publication 24-526
Additional Information of Eligibility:
Eligible Applicants: Eligibility is limited to the alumni of U. S. government-sponsored exchange programs, who are citizens or residents of Georgia.
(https://alumni.state.gov/list-exchange-programs) Other Eligibility Requirements: Applicants are only allowed to submit a maximum of two proposal per individual.
If more than two proposals is submitted from an individual, all proposals from that individual will be considered ineligible for funding.
If a group of alumni cooperate to submit a joint project, the requested amount cannot exceed $20,000.
The submitting applicant should be an individual alumnus/alumna or the group of alumni, but the grant can be awarded to the organization partnering in the project.
If the organization will be the awardee, they need to present active SAM.gov registration prior to awarding process.
SAM.gov registration for applicant individuals is not required.
Full Opportunity Web Address:
http://www.nsf.gov/publications/pub_summ.jsp?ods_key=nsf24526
Contact:
Agency Email Description:
terrin.brown@fda.hhs.gov
Agency Email:
Date Posted:
2024-01-15
Application Due Date:
Archive Date:
2024-04-30
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