OpportunityTitle: Development of Advanced Analytical Methods for the Characterization of Iron Carbohydrate Complex - Ferric Derisomaltose (U01) Clinical Trials Not Allowed
AdditionalInformationOnEligibility: Eligible Organizations  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)   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)
Description: Development of advanced analytical methods for the characterization and comparative analysis of complex products are important for linking product attributes to safety, quality and clinical performance, which is helpful for facilitating development of generic complex products. The purpose of this study is to develop advanced analytical methods for the characterization and analysis of ferric derisomaltose which is a complex drug product. The results from this study will help the development and review of generic ferric derisomaltose.
GrantorContactEmailDescription: shashi.malhotra@fda.hhs.gov
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592