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

US · MD Food and Drug Administration (FDA) grant open #FOR-FD-24-002

Summary

The FDA is seeking research to develop Physiologically Based Pharmacokinetic (PBPK) model-based mechanistic In Vitro-In Vivo Correlations (IVIVCs) for long-acting injectable suspensions and implants. This is a U01 cooperative research grant mechanism, meaning the FDA will have substantial scientific and/or programmatic involvement. Clinical trials are optional under this opportunity. The effort aims to advance drug product development science and regulatory tools for extended-release parenteral dosage forms.

What they want

Recipients will develop PBPK model-based mechanistic IVIVCs applicable to long-acting injectable (LAI) suspensions and implantable drug delivery systems. Work is expected to include computational modeling, in vitro dissolution/release testing, and potentially clinical pharmacokinetic data integration to establish predictive IVIVC frameworks. Clinical trial components are optional.
Technical requirements
  • Development of PBPK model-based mechanistic IVIVCs
  • Focus on long-acting injectable suspensions and implants
  • Clinical trial component optional

How they evaluate

Submission: Grants.gov electronic submission (standard HHS/FDA U01 grant application process)

Risks & flags

  • Highly specialized and narrow scientific scope (PBPK modeling for LAI suspensions and implants) may limit competitive pool to a small number of academic or industry research groups with prior FDA-aligned work in this niche area.
  • Forecasted status only — full FOA details, budget limits, and evaluation criteria not yet published, limiting ability to assess full fairness of competition.

Market context

inferred from NAICS
R&D in Physical, Engineering, Life Sciences (except Nanotech & Biotech)
NAICS 541715
US market size
$95B
Typical award
$100K – $50M+
Typical buyers
DoDNSFNIHNASADOE
Commonly required
DCAA-compliant accountingITARCMMC L2
Developing PBPK Model-Based Mechanistic IV…
$unknown
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