OpportunityTitle: Computational Fluid Dynamics (CFD) Models to Aid the Development of Generic Inhalation Products (U01) Clinical Trials Optional
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)   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.  Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Description: Current U.S. Food and Drug Administration product-specific guidances for orally inhaled drug products such as metered dose inhalers (MDIs) and dry powder inhalers (DPIs) typically recommend using a weight-of-evidence approach for demonstrating bioequivalence (BE) that includes in vitro studies, an in vivo pharmacokinetics study, and either an in vivo pharmacodynamics or comparative clinical endpoint BE study. To produce a generic MDI or DPI that can meet acceptance criteria from all these recommended studies, it would be useful to have an enhanced understanding of the relationships between in vitro study metrics and the rate and extent of drug delivery to the targeted lung tissue. Computational fluid dynamics (CFD) is a technique capable of predicting these relationships between in vitro study metrics and regional lung deposition. The purpose of this funding opportunity announcement is to use CFD to produce verified and validated predictions of regional lung deposition for at least one currently marketed MDI or DPI in human upper and lower airways and to develop an in vitro-in vivo correlation (IVIVC) between model predictions and at least one relevant in vitro metric. Generic drug developers may then use this IVIVC to interpret in vitro results in a manner that may increase confidence in their products prior to in vivo testing
GrantorContactEmailDescription: shashi.malhotra@fda.hhs.gov
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592