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

$250,000
Applications Due: Rolling
Federal
HHS-FDA (Food and Drug Administration)

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

States
All
Regions
All
Eligible Entities
State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal organizations, Public housing authorities, Nonprofits

Funding

Program Funding
Award Ceiling
$250,000
Award Floor
$250,000
Award Count
1

Timing

Posted Date
November 24, 2023
App Status
No Longer Accepting Applications
Pre-app Deadline
Application Deadline

Funder

Funding Source
Source Type
Federal
Contact Name
Contact Email
Contact Phone
--

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