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Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
ID: 351126Type: Forecasted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$250K - $250K

Eligible Applicants

Unrestricted

Funding Category

Consumer Protection

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
  1. 1
    Forecast Posted Not available
  2. 2
    Forecast Due Not available
  3. 3
    Posted Nov 24, 2023 12:00 AM
  4. 4
    Due Not available
Description

The Food and Drug Administration (FDA) is offering a federal grant opportunity titled "Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)". This grant falls under the category of Consumer Protection and is a Cooperative Agreement type of funding instrument. The grant does not require cost sharing or matching.

The purpose of this funding opportunity is to support research and development in non-invasive technologies, specifically quantitative tomography-based methods, to evaluate 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 funded work aims to develop an accurate, sensitive, and reproducible approach to measure the amount of drug present in the skin at various depths below the surface. This approach will be used to monitor the cutaneous pharmacokinetics (PK) of the drug over time. The ultimate goal is to develop a scientifically valid in vivo cutaneous PK-based approach that can efficiently demonstrate the bioequivalence (BE) of topical products.

The grant has an award ceiling and floor of $250,000, and it is expected that one award will be made. The eligibility for this grant is unrestricted, meaning any applicant organization can apply. However, each application must be scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time.

For more information or to apply for this grant opportunity, you can contact Terrin Brown, the grantor, at terrin.brown@fda.hhs.gov or by phone at 240-338-7494. The deadline for this grant is forecasted to be in the fiscal year 2024.

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