Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
Food and Drug Administration
At a glance
This funding opportunity is offered by Food and Drug Administration. Awards are up to $250,000.
Classification and identifiers
- Solicitation number
- FOR-FD-24-004
- Assistance listing (CFDA)
- 93.103
Amount
$250,000
Who can apply
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 Application...
About this opportunity
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 t...
Related opportunities
- CCRP Initiative: Promoting a Basic Understanding of Chemical Threats to Skin (R01 Clinical Trial Not Allowed)National Institutes of HealthCloses Nov 2028Up to $300K
- Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not AllowedFood and Drug AdministrationUp to $300K
- Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial OptionalFood and Drug AdministrationUp to $500K
- Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial OptionalFood and Drug AdministrationUp to $300K
- NIAMS P30 Centers Program (P30 - Clinical Trial Not Allowed)National Institutes of Health
- Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not AllowedFood and Drug AdministrationUp to $250K