Saturday, November 23, 2024 11/23/2024

Computational Biology (Cobi) Tools as a Framework for Physiologically-Based Pharmacokinetic/Pharmacodynamic Model Extrapolation from Rabbit to Human for Ophthalmic Drug Products

Award Number: U01FD006929
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By:

View Award Abstract

Project Summary/Abstract: Evaluating bioequivalence of ophthalmic drug products in humans is challenging for ethical and practical reasons. Often, animal models are used to evaluate ophthalmic bioequivalence. Unfortunately, methods for translation of animal model results to humans has proven elusive. There is a critical need to develop computational tools to assist with interspecies translation. Physiologically-based model extrapolation can provide a means for explaining interspecies differences in pharmacokinetics (PK) and pharmacodynamics (PD). The objective of the proposed work is to develop a translational tool framework for capturing interspecies differences in the PK and PD of ophthalmic drug products using physiologically-based model extrapolation methods. To facilitate framework development, we will collect physiologically-based rabbit and human ophthalmic PK and PD models from literature. Model components will be integrated with our existing models to create optimized models. Our team’s experience in multiscale ophthalmic modeling enables the framework to include models of varying complexity (compartmental, quasi-3D, 2D and novel 2.5D models), which provides are more complete picture of potential extrapolation solutions versus implementing a single model type. Model details (i.e. modeled tissues, segment, complexity, physiological phenomena, etc.) will be organized in a spreadsheet which will include model capabilities and limitations. In parallel, an opensource database comparing rabbit and human anatomical and physiological parameter values/value ranges will be created. Collected and optimized rabbit PK and PD models will be extrapolated/scaled up to human models by changing anatomical, physiological and biophysical parameter values. Common dosing scenarios (topical and intravitreal administration of solutions, solid suspensions and emulsions) will be simulated using extrapolated, collected and optimized human ophthalmic PK and PD models for comparison purposes. Comparison of simulation results will enable identification of the current translational knowledge gaps. The framework will allow evaluation of potential solutions to closing these knowledge gaps. This project will enhance public health by improving regulatory confidence, speed and efficiency in the approval process for new and generic ophthalmic drug products and by decreasing costs to the public.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = -$13,870 )
2024	2022	CFD RESEARCH CORPORATION	6820 MOQUIN DR NW	HUNTSVILLE	AL	35806	MADISON	USA	Food and Drug Administration Research	000	3	4/27/2024	NON-COMPETING CONTINUATION	-$13,870
														Subtotal = -$13,870

Issue Date FY: 2022 ( Subtotal = $39,849 )
2022	2022	CFD RESEARCH CORPORATION	6820 MOQUIN DR NW	HUNTSVILLE	AL	35806	MADISON	USA	Food and Drug Administration Research	000	3	6/7/2022	NON-COMPETING CONTINUATION	$39,849
														Subtotal = $39,849

Issue Date FY: 2021 ( Subtotal = $179,978 )
2021	2021	CFD RESEARCH CORPORATION	6820 MOQUIN DR NW	HUNTSVILLE	AL	35806	MADISON	USA	Food and Drug Administration Research	000	2	8/3/2021	NON-COMPETING CONTINUATION	$179,978
														Subtotal = $179,978

Issue Date FY: 2020 ( Subtotal = $179,944 )
2020	2020	CFD RESEARCH CORPORATION	701 MCMILLIAN WAY STE D	HUNTSVILLE	AL	35806	MADISON	USA	Food and Drug Administration Research	000	1	5/18/2020	NEW	$179,944
														Subtotal = $179,944

Grand Total All Awards = $385,901

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Computational Biology (Cobi) Tools as a Framework for Physiologically-Based Pharmacokinetic/Pharmacodynamic Model Extrapolation from Rabbit to Human for Ophthalmic Drug Products

Award Number: U01FD006929

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer