Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

PBPK Modeling and Simulation for Ocular Dosage Forms

Award Number: U01FD005211
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/10/2014
PERIOD OF PERFORMANCE END DATE: 08/31/2018

Group Awards By:

View Award Description

PBPK Modeling and Simulation for Ocular Dosage Forms - Ocular Dosing Abstract The Office of Generic Drugs (OGD) is tasked, among other things, with reviewing sponsor applications for ocular dosage forms that purport to be bioequivalent to approved formulations for the same drug. Sponsor companies want to have high confidence that applications they submit for dosage forms thought to be bioequivalent will receive favorable reviews. Software that embodies mechanistic absorption modeling (MAM) and physiologically based pharmacokinetics (PBPK) can be a useful tool to reduce the time and expense involved in determining the likelihood that a new formulation will be bioequivalent to an approved dosage form for both industry scientists and regulators. Developing a state-of-the-art capability for ocular MAM/PBPK software requires an extensive knowledge base to serve as the scientific foundation, talented scientists to apply the knowledge base in the development of useful equations and logic suitable for software, high-level computer programming skills to encode the equations and logic into user-friendly software, and experienced scientists to test, validate, document, and support the software for use by others not involved in its development. This proposed project will advance the state-of-the-art for ocular MAM/PBPK software through a combination of expanding the existing knowledge base, development and implementation of enhanced physiological models for human and animal eyes in the existing Ocular Compartmental Absorption and Transit™ (OCAT™) model within the GastroPlus™ software program, and validation and documentation of the resulting software for use by others. By basing the final software program on the well-established and validated OCAT model, which is in use in the pharmaceutical industry today, we will be able to focus project resources entirely on advancing the capabilities of the model rather than having to develop new code for the core program and its many support capabilities (e.g., integration, plotting, Parameter Sensitivity Analysis, Population Simulations, and drug-drug interactions). Throughout the effort, we will maintain close contact with the FDA program manager and the Consortium for Ocular Simulation and Modeling (COSM) that we propose to form with our collaboration partners and the FDA to ensure the project team focuses on software developments and new experimental work that will result in developing the optimum software capabilities for ocular dosage form development and comparison, within the scope of the project.


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: 2021 ( Subtotal = -$792,972 )
2021	2016	SIMULATIONS PLUS, INC.	42505 10TH ST W	LANCASTER	CA	93534	LOS ANGELES	USA	Food and Drug Administration Research	002	3	8/16/2021	NON-COMPETING CONTINUATION	-$200,000
2021	2016	SIMULATIONS PLUS, INC.	42505 10TH ST W	LANCASTER	CA	93534	LOS ANGELES	USA	Food and Drug Administration Research	001	3	7/8/2021	NON-COMPETING CONTINUATION	-$200,000
2021	2016	SIMULATIONS PLUS, INC.	42505 10TH ST W	LANCASTER	CA	93534	LOS ANGELES	USA	Food and Drug Administration Research	003	3	9/13/2021	NON-COMPETING CONTINUATION	-$200,000
2021	2015	SIMULATIONS PLUS, INC.	42505 10TH ST W	LANCASTER	CA	93534	LOS ANGELES	USA	Food and Drug Administration Research	000	2	7/8/2021	NON-COMPETING CONTINUATION	-$192,972
														Subtotal = -$792,972

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2016	SIMULATIONS PLUS, INC.	42505 10TH STREET W	LANCASTER	CA	93534	LOS ANGELES	USA	Food and Drug Administration Research	000	3	8/24/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $200,000 )
2016	2016	SIMULATIONS PLUS INC	42505 10TH STREET WEST	LANCASTER	CA	93534	LOS ANGELES	USA	Food and Drug Administration Research	000	3	8/24/2016	NON-COMPETING CONTINUATION	$200,000
														Subtotal = $200,000

Issue Date FY: 2015 ( Subtotal = $200,000 )
2015	2015	SIMULATIONS PLUS INC	42505 10TH STREET WEST	LANCASTER	CA	93534	LOS ANGELES	USA	Food and Drug Administration Research	000	2	8/24/2015	NON-COMPETING CONTINUATION	$200,000
														Subtotal = $200,000

Issue Date FY: 2014 ( Subtotal = $200,000 )
2014	2014	SIMULATIONS PLUS INC	42505 10TH STREET WEST	LANCASTER	CA	93534	LOS ANGELES	USA	Food and Drug Administration Research	001	1	9/11/2014	NEW	$0
2014	2014	SIMULATIONS PLUS INC	42505 10TH STREET WEST	LANCASTER	CA	93534	LOS ANGELES	USA	Food and Drug Administration Research	000	1	9/10/2014	NEW	$200,000
														Subtotal = $200,000

Grand Total All Awards = -$192,972

Top

All Categories

About

Search

Reports

Data Submission

Award Information

PBPK Modeling and Simulation for Ocular Dosage Forms

Award Number: U01FD005211

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/10/2014

PERIOD OF PERFORMANCE END DATE: 08/31/2018

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer