FDA CDER Funding Opportunity Announcement

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FDA CDER Funding Opportunity Announcement

Funding Opportunity Announcement:

Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) (RFA-FD-18-018)

Objective:

The purpose of this project is to develop and implement a virtual bioequivalence trial simulation platform that can be used to perform population-based statistical analysis in complex and computationally intensive physiologically based pharmacokinetic (PBPK) models developed to describe the absorption, distribution, and elimination of active pharmaceutical ingredients formulated in complex and non-complex dosage forms administered via oral or non-oral routes. The developed virtual bioequivalence trial simulation platform will be used by all stakeholders engaged in generic drug development including regulatory agencies, pharmaceutical industry, and academia to generate predictions on in vivo drug product performance, to perform bioequivalence assessments between brand name and generic drug products, and to inform regulatory decisions relating to generic drug development.

Letter of Intent Due Date: May 4, 2018

Application Due Date: June 20, 2018, by 11:59 PM Eastern Time