This scholarship page was last updated on 06 January 2023. Some details may have changed since then. Please check the Department of Health and Human Services Food and Drug Administration website or the Department of Health and Human Services Food and Drug Administration page for current opportunities.

Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional

Department of Health and Human Services Food and Drug Administration
Type

Research/project funding

Posted on:

Application Deadline:

Expired

Reference Number

RFA-FD-23-015

The purpose of this funding opportunity is to develop and validate an enhanced mechanistic PBPK model to reliably describe the skin permeation of active pharmaceutical ingredients in topical drug products applied on the skin surface of virtual subjects by accounting for the drug product quality attributes and the metamorphosis these products undergo post application. The goal is to develop an in silico tool and to assess its capability to predict skin absorption for reference listed drug and test drug products considering their potentially different formulation compositions and quality attributes and the dynamic changes they undergo post application. This in silico tool (validated using appropriate datasets) is intended to identify parameters that may impact therapeutic equivalence between a reference listed drug and a test drug product applied on the skin and to inform decisions on generic drug development for these products.
Categories: Consumer Protection, Science and Technology and other Research and Development.

More Information

Type

Research/Project Funding

Posted on:

Application Deadline:

Expired

Reference Number

RFA-FD-23-015

United States