Food and Drug Administration

Description

The purpose of this study is to investigate in vitro-in vivo correlations of ophthalmic intravitreal implants. Specifically, an in vitro dissolution test which correlates with in vivo ocular absorption should be investigated. In vivo studies should be conducted in an appropriate animal model.Suitable bioequivalence methods are lacking for generic ophthalmic implants. The results from this project will help to understand the relationship between in vitro release and in vivo release, and the findings will be used to help determine bioequivalence study recommendations for generic ophthalmic intravitreal implants.

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)
• 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

Jennerfer Torres-Hernandez <br/>Grants Management Specialist <br/>Phone 301-827-9607
Jennerfer.Torres-Hernandez@fda.hhs.gov