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Development of PBPK simulation for long-acting injectable microspheres

Award Number: U01FD005463
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2015
PERIOD OF PERFORMANCE END DATE: 08/31/2018

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Development of PBPK simulation for long-acting injectable microspheres - LAI Microspheres Abstract The Office of Generic Drugs (OGD) is tasked, among other things, with reviewing sponsor applications for long-acting injectable microsphere-based 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 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 LAI microsphere 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 develop PBPK software for LAI microspheres through a combination of expanding the existing knowledge base, development and implementation of enhanced physiological models for human and animal dosing tissues in the existing 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 GastroPlus PBPK model, which is in wide 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 LAI Microspheres (CLAIM) 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 LAI microsphere 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 = -$159,183 )
2021	2017	SIMULATIONS PLUS, INC.	42505 10TH ST W	LANCASTER	CA	93534	LOS ANGELES	USA	Food and Drug Administration Research	000	3	7/8/2021	NON-COMPETING CONTINUATION	-$159,183
														Subtotal = -$159,183

Issue Date FY: 2017 ( Subtotal = $200,000 )
2017	2017	SIMULATIONS PLUS, INC.	42505 10TH STREET W	LANCASTER	CA	93534	LOS ANGELES	USA	Food and Drug Administration Research	000	3	8/8/2017	NON-COMPETING CONTINUATION	$200,000
														Subtotal = $200,000

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	2	8/25/2016	NON-COMPETING CONTINUATION	$200,000
														Subtotal = $200,000

Issue Date FY: 2015 ( Subtotal = $197,219 )
2015	2015	SIMULATIONS PLUS INC	42505 10TH STREET WEST	LANCASTER	CA	93534	LOS ANGELES	USA	Food and Drug Administration Research	000	1	9/1/2015	NEW	$197,219
														Subtotal = $197,219

Grand Total All Awards = $438,036

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Development of PBPK simulation for long-acting injectable microspheres

Award Number: U01FD005463

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/15/2015

PERIOD OF PERFORMANCE END DATE: 08/31/2018

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