OpportunityTitle: Dermal Physiologically-based Pharmacokinetic (PBPK) Models Accounting for the Absorption and Evaporation of Vehicle/Co-solvent following the Application of Generic Dermatological Products (U01)
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:     o   Hispanic-serving Institutions    o   Historically Black Colleges and Universities (HBCUs)    o   Tribally Controlled Colleges and Universities (TCCUs)     o   Alaska Native and Native Hawaiian Serving Institutions    o   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: The overall objective of this funding opportunity is to develop an enhanced mechanistic PBPK model for generic dermatological drug products by taking account the absorption and evaporation of vehicle/co-solvent simultaneously and implementing the effect of these two dynamic processes on the permeation of drug molecule through skin. The developed model will be utilized to inform decisions on generic dermatological product development, to enhance the understanding of the effect of metamorphosis of dermatological drug products on skin absorption, and to predict the local and systemic exposure of drug molecule following topical application of dermatological drug products.
GrantorContactEmailDescription: shashi.malhotra@fda.hhs.gov
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592