Food and Drug Administration

Description

The purpose of this funding opportunity is to elucidate how pharmacokinetic principles and concepts (e.g., dose, fraction of drug absorbed, apparent volume of distribution, Cmax, AUCinfinity) should be applied or adapted when evaluating the rate and extent to which a topically applied compound becomes available in the dermis, at or near a site of action within the skin, and to evaluate the relative sensitivity of in vivo dermal pharmacokinetic methods to discriminate differences in drug concentrations in the skin. The expectation is that the funded work will establish appropriate designs and analyses for in vivo dermal microdialysis (dMD) or dermal open flow microperfusion (dOFM) studies to evaluate topical bioavailability and bioequivalence based upon appropriate dermal pharmacokinetic endpoints.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• Small businesses
• Others

Contact

Shashi Malhotra <br/>Grants Management Specialist <br/>Phone 2404027592
shashi.malhotra@fda.hhs.gov