Scout | FOR-FD-24-002: PBPK Mechanistic IVIVC for Long‑Acting Injectable Suspensions and Implants (U01)

grant FOR-FD-24-002

PBPK Mechanistic IVIVC for Long‑Acting Injectable Suspensions and Implants (U01)

Summary

This U01 opportunity supports development of bottom‑up physiologically based pharmacokinetic (PBPK) models to create mechanistic in vitro‑in vivo correlations (IVIVCs) for two long‑acting injectable (LAI) categories: crystalline suspensions and polymer‑based implants. Projects should link formulation attributes, drug/polymer properties, and physiology with targeted in vitro and in vivo studies…

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 …

Funding Source

Agency: Food and Drug Administration

Awards & funding

Total Funding: $600,000

Award Ceiling: $300,000

Eligibility

For profit organizations other than small businesses

Native American tribal governments (Federally recognized)

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

Public and State controlled institutions of higher education

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

Supporting links

grants.gov

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