Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
ID: 351804Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $300K

Eligible Applicants

Unrestricted

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
  1. 1
    Forecast Posted Not available
  2. 2
    Forecast Due Not available
  3. 3
    Posted Jan 15, 2024 12:00 AM
  4. 4
    Due Apr 8, 2024 12:00 AM
Description

The Food and Drug Administration (FDA) has posted a grant opportunity titled "Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional". This grant aims to develop physiologically based pharmacokinetic (PBPK) model-based mechanistic in vitro in vivo correlations (IVIVCs) for long-acting injectables (LAIs) such as crystalline suspensions and polymer-based implants.

The objective of this research proposal is to develop a bottom-up mechanistic PBPK model for these two LAI categories by considering their distinct characteristics. The goal is to predict the in vivo release mechanism of each LAI drug product type by accounting for the influence of critical formulation attributes. The development of the model will involve suitable in vitro and in vivo experiments, as well as validation using a suitable preclinical animal model.

By utilizing PBPK modeling, this research will provide insights into how the physicochemical properties of drug molecules/polymer, implant-specific properties, critical formulation attributes, and physiology influence the in vivo release mechanisms and disposition characteristics of LAI drug products. Additionally, the developed mechanistic PBPK model can help define the "safe space" for critical formulation attributes, explain sources of pharmacokinetic variability, and extrapolate predictions to human subjects by leveraging animal model data and accounting for species-specific physiological differences.

The grant has an award ceiling of $300,000 and an estimated total program funding of $300,000. It is expected that two awards will be granted. The opportunity falls under the category of Food and Nutrition and is a discretionary funding activity. The close date for applications is April 8, 2024, and the archive date is April 30, 2024.

For more information, you can visit the RFA-FD-24-006 Funding Opportunity Announcement. If you have any questions, you can contact Terrin Brown, the grantor, at terrin.brown@fda.hhs.gov.

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