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Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)

Open

Food and Drug Administration

Deadline: federal

Updated: Oct 30, 2025

Summary

The purpose of this grant is to support the research and development of non-invasive technologies for characterizing the pharmacokinetics of topically applied drugs in the skin, aiming to create a reliable method for measuring drug presence at various skin depths. Eligible applicants include nonprofit organizations, government entities, for-profit businesses, and educational institutions. Interested parties can submit multiple distinct applications, but must avoid submitting overlapping proposals; for more information, applicants can contact the grantor via email at terrin.brown@fda.hhs.gov.

Full Description

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

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).

Grantor contact information

Description

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Email

terrin.brown@fda.hhs.gov

terrin.brown@fda.hhs.gov

Apply on official siteUpdated Oct 30, 2025

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