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AusGrant
Federal Forecasted GRANTS-GOV-351078

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

Food and Drug Administration (HHS) · Competitive · Science & Technology

At a glance

Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional is a federal competitive grant from Food and Drug Administration for the science & technology sector. Funding is up to $300K. Eligible applicants: Public housing authorities/Indian housing authorities; Public and State controlled institutions of higher education; City or township governments; Special district governments; Small businesses; County governments; Nativ. Applications are accepted on a rolling basis. Apply via the official listing at www.grants.gov.

Amount
Up to $300K
Deadline
Rolling
Type
Competitive
Status
Forecasted

About this program

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.

Who can apply

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

How to apply

Apply through Grants.gov using funding opportunity number FOR-FD-24-002. Register your organization (SAM.gov + Grants.gov) before the deadline, then submit the application package listed in the official notice.

Apply at official source