Food and Drug Administration

Description

Use of “trained observers” for clinical evaluation of transdermal irritation has the potential for observer bias and variability in assessment since the various transdermal systems that are applied on subjects for such studies are usually visually dissimilar. Use of digital images and image analysis software/s has the potential to enhance consistency and reliability of the measurements compared to visual assessment. The purpose of this study is to help evaluate if digital imaging can be used to quantify transdermal irritation and for non-inferiority analysis of generic transdermal systems.

Who can apply

• 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 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
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

Eric Bozoian <br/>Grants Management Specialist <br/>Phone 2404027623
eric.bozoian@fda.hhs.gov