Grants / Department of Health and Human Services / Food and Drug Administration

Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional

Forecast Forecast, no dates yet Opportunity FOR-FD-24-002

• Award ceiling$300,000
• Award floornot stated
• Expected awards2
• Total funding$600,000
• Cost sharingNot required
• Funding typeCooperative Agreement

Key dates

Who can apply

This opportunity is open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities/Indian housing authorities
• Native American tribal organizations (other than Federally recognized tribal governments)
• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
• Private institutions of higher education
• For profit organizations other than small businesses
• Small businesses
• Others (see text field entitled "Additional Information on Eligibility" for clarification)

Independent 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

More grants for nonprofits, colleges and universities, state and local governments, tribes, small businesses, businesses.

Is this a realistic fit?

• No cost sharing or match is required.

What the grant funds

The objective of this research proposal is to develop physiologically based pharmacokinetic (PBPK) model-based mechanistic in vitro in vivo correlations (IVIVCs) for two major types of long acting injectables (LAIs) such as crystalline suspensions and polymer-based implants by considering their distinct characteristics. The goal of the project is to develop a bottom-up mechanistic PBPK model for these two LAI categories by accounting for the influence of critical formulation attributes of each LAI drug product type to predict its in vivo release mechanism. The model formulation parameters and relevant physiology should be informed with suitable in vitro and in vivo experiments. A suitable preclinical animal model can be used to validate the PBPK model based IVIVCs for both LAI suspensions and polymer based implants. The use of PBPK modelling provides a unique opportunity to understand how the physicochemical properties of drug molecules/polymer, implant specific properties, critical formulation attributes, and physiology, among other things, influence the in vivo release mechanisms of LAI drug products and their disposition characteristics. Moreover, once developed, a mechanistic PBPK model can help to define the 'safe space' for critical formulation attributes relevant to the reference listed drug (RLD) product, explain sources of PK variability and extrapolate predictions to human subjects by leveraging animal model data and by accounting for species-specific physiological differences.

Category: Food and Nutrition, Health, Science and Technology and other Research and Development.

How to apply

1. Read the full notice and attachments on Grants.gov. The notice is the official source for deadlines and requirements.
2. Make sure your organization has an active SAM.gov registration and Unique Entity ID; registration can take several weeks.
3. Register on Grants.gov and submit through Workspace before the deadline and time given in the notice. Our application guide walks through each step.

Questions go to Terrin Brown, Grants Management Specialist, Terrin.Brown@fda.hhs.gov, 240-402-7610.

Open the official notice