Grants / Department of Health and Human Services / Food and Drug Administration

RFA-FD-22-017: Cutaneous pharamcokinetic-based approaches to establish bioequivalence of topically applied drug products

Closed Closed March 31, 2022 Opportunity RFA-FD-22-017 ☆ Save

This grant is closed. A newer notice from the same program is open now: Flexible Funding Model - Advancing Domestic Mutual Reliance Through Strengthened Infrastructure Development and Maintenance for Manufactured Food Regulatory Programs (PAR-27-017). Status: Rolling or no fixed deadline. It is in our archive of Food and Drug Administration notices from 2022.

• Award ceiling$1.5 million
• Award floor$50,000
• Total funding$1.0 million
• Expected awards2
• Cost sharingNot required
• Funding typeCooperative Agreement

Key dates

Who can apply

This opportunity was open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.

More grants for nonprofits, colleges and universities, state and local governments, tribes, small businesses, businesses.

Is this a realistic fit?

• Past Food and Drug Administration Research awards averaged $1.3 million; this notice allows up to $1.5 million per award.
• Most of the program's money (35% over five years) went to nonprofits.
• No cost sharing or match is required.

What the grant funds

The primary objective of this funding opportunity is to optimize clinical study designs and data analysis techniques that can support a comparative assessment of the relative bioavailability of topically administered drugs, and which can support a demonstration of BE for prospective generic topical products. The specific aims of this research would include comparing in vivo cutaneous PK measurements by independent techniques (e.g., dermal Open Flow Microperfusion (dOFM), dermal microdialysis (dMD), spectroscopic tomography), exploring the removal of the topical formulations at different time points and characterizing the PK profiles of the test and reference products; developing data analysis techniques (described in detail below); and identifying appropriate PK endpoints for the evaluation of topical BE. Based on the multidisciplinary nature of the research supported by this funding opportunity, it is encouraged that researchers with expertise in measuring cutaneous drug concentrations (e.g., experts in techniques such as dOFM, dMD and/or spectroscopy based techniques) collaborate with experts in PK data analysis and with statisticians, to achieve the overall objectives of the research. Specific areas of scientific interest would include the following: 1. Expansion of the current theoretical framework to describe the relationship between the concentration of drug sampled by a given technique (dOFM, dMD, or spectroscopy based techniques) and the actual amount of drug in the epidermis/dermis, and the relationships between the free drug vs protein-bound drug sampled, when relevant, so that not only could the relative amounts of drug in the epidermis/dermis be compared, but also that the actual drug exposures at the site of action could be calculated. 2. Comparison of the available techniques for characterizing cutaneous PK in parallel, within the same clinical setting. (e.g., comparison of dOFM or dMD with other technique(s) that monitor cutaneous PK, like spectroscopic tomography, ideally using commercially available instrumentation). 3. Exploration of different study designs to characterize the cutaneous PK profiles for topical drugs that may not reach the maximum drug concentration (Cmax) within the 24 hours of administration. 4.

Category: Consumer Protection, Health, Science and Technology and other Research and Development.

Applying now

This notice no longer takes applications. Apply under the newer notice, PAR-27-017, which is open now.

The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.