OpportunityTitle: In vitro-In vivo Correlations of Ocular Implants
AdditionalInformationOnEligibility: Higher Education Institutions    Public/State Controlled Institutions of Higher Education   Private Institutions of Higher Education   The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:     Hispanic-serving Institutions   Historically Black Colleges and Universities (HBCUs)   Tribally Controlled Colleges and Universities (TCCUs)   Alaska Native and Native Hawaiian Serving Institutions   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)   Nonprofits Other Than Institutions of Higher Education    Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)   Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)   For-Profit Organizations    Small Businesses   For-Profit Organizations (Other than Small Businesses)   Governments    State Governments   County Governments   City or Township Governments   Special District Governments   Indian/Native American Tribal Governments (Federally Recognized)   Indian/Native American Tribal Governments (Other than Federally Recognized)   Eligible Agencies of the Federal Government   U.S. Territory or Possession   Other    Independent School Districts   Public Housing Authorities/Indian Housing Authorities   Native American Tribal Organizations (other than Federally recognized tribal governments)   Faith-based or Community-based Organizations   Regional Organizations   Non-domestic (non-U.S.) Entities (Foreign Institutions)   Foreign Institutions  Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.  Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
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.
GrantorContactEmailDescription: Jennerfer.Torres-Hernandez@fda.hhs.gov
GrantorContactText: Jennerfer Torres-Hernandez &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 301-827-9607