Value AD
CAN BE
ALTERNATIVE
INVESTMENT
Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
FOR-FD-24-004
Terrin Brown Grantor
Funding Opportunity Number: FOR-FD-24-004
Opportunity Category: Discretionary
Expected Number of Awards: 1
CFDA Number(s): 93.103 -- Food and Drug Administration Research
Cost Sharing or Matching Requirement: No
Posted Date: Nov 24, 2023 12:00:00 AM EST
Closing Date: N/A
Award Ceiling: $250000
Award Floor: $250000
Eligible Applicants: Others (see text field entitled "Additional Information on Eligibility" for clarification),Public housing authorities/Indian housing authorities,State governments,Public and State controlled institutions of higher education,Small businesses,For profit organizations other than small businesses,Native American tribal governments (Federally recognized),Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education,Independent school districts,Private institutions of higher education,Special district governments,Native American tribal organizations (other than Federally recognized tribal governments),Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility",Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education,County governments,City or township governments
Additional Information on Eligibility: Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH or FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.•A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.•An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
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.
