In Vitro Based Approaches to Evaluate the Bioequivalence of Prospective Generic Rectal and Vaginal Products (U01) Clinical Trial Not Allowed

https://www.grants.gov/web/grants/view-opportunity.html?oppId=344260
Award Amount
$1,000,000.00
Maximum Amount
$1,000,000.00
Assistance Type
Other
Funding Source
Federal
Implementing Entity
Food and Drug Administration
Due Date
Where the Opportunity is Offered
All of California
Eligible Applicant
State Government
County/Local Government
Special District
School
Tribal Government
NGO
Nonprofit
Business
Other
Additional Eligibility Information
Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationThe following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:Hispanic-serving InstitutionsHistorically Black Colleges and Universities (HBCUs)Tribally Controlled Colleges and Universities (TCCUs)Alaska Native and Native Hawaiian Serving InstitutionsAsian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher EducationNonprofits 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 OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Institutions)
Contact
Shashi Malhotra
Description

The purpose of this funding opportunity is to support research and development that will characterize the specific and unique considerations relevant to evaluating the bioequivalence (BE) of rectal and vaginal (topical) drug products. A specific emphasis of this funding opportunity involves the development of biorelevant performance tests as a component of product characterization-based BE approaches.

Category
Other

Similar Oppportunities

Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed
Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models
Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional
Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed
OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed
Last Updated