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PBPK and Population Modeling Seamlessly Linked to Clinical Trial Simulation in an Open-Source Software Platform

Award Number: U01FD006549
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By Issue Date FY or Funding FY:

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The goal of this project is to develop a comprehensive, open-source software platform for bioequivalence (BE) study design. Components of the platform will implement a framework for population modeling based on physiological- ly-based pharmacokinetic (PBPK) models integrated with a trial simulator. The framework will consist of: 1) Model structures appropriate for a wide range of compounds and routes of administration; 2) Diverse and robust parametric and nonparametric methods for population modeling to update prior PBPK model parameter value distributions with individual data; 3) Simulation of a variety of BE trial designs with standard and novel optimal sampling strategies; 4) Software implementation of an integrated workflow. To build the framework, the project will focus on the following aims that align with the workflow. Aim 1: Add inhalational and dermal penetration routes to existing intravenous and oral routes in the Open Systems Pharmacology (OSP) Suite and an in vitro-in vivo formulation/dissolution correlation module. Aim 2: Integrate a variety of parametric and nonparametric population algorithms based in part upon the Pmet- rics package for R to update PBPK models when individual data are available. Aim 3: Develop a BE trial simulator by re- purposing existing capabilities within OSP and Pmetrics to simulate output for a wide range of BE trial designs, incorpo- rating standard and novel optimal sampling algorithms and existing R modules for sample size calculations and analysis of predicted trial outcomes. Aim 4: Implement a seamlessly integrated software workflow of model building, updating and simulating, hosted on the OSP platform, and using state of the art engineering to create a freely available, open- source product.


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: 2023 ( Subtotal = $0 )
2023	2020	CHILDRENS HOSPITAL LOS ANGELES	4650 W SUNSET BLVD	LOS ANGELES	CA	90027	LOS ANGELES	USA	Food and Drug Administration Research	000	3	12/20/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	CHILDRENS HOSPITAL LOS ANGELES	4650 SUNSET BLVD	LOS ANGELES	CA	90027	LOS ANGELES	USA	Food and Drug Administration Research	000	3	11/11/2020	NON-COMPETING CONTINUATION	$0
2021	2020	CHILDRENS HOSPITAL LOS ANGELES	4650 SUNSET BLVD	LOS ANGELES	CA	90027	LOS ANGELES	USA	Food and Drug Administration Research	001	3	8/12/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $297,023 )
2020	2020	CHILDRENS HOSPITAL LOS ANGELES	4650 SUNSET BLVD	LOS ANGELES	CA	90027	LOS ANGELES	USA	Food and Drug Administration Research	001	3	8/13/2020	NON-COMPETING CONTINUATION	$297,023
2020	2019	CHILDRENS HOSPITAL LOS ANGELES	4650 SUNSET BLVD	LOS ANGELES	CA	90027	LOS ANGELES	USA	Food and Drug Administration Research	000	2	12/13/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $297,023

Issue Date FY: 2019 ( Subtotal = $299,474 )
2019	2019	CHILDRENS HOSPITAL LOS ANGELES	4650 SUNSET BLVD	LOS ANGELES	CA	90027	LOS ANGELES	USA	Food and Drug Administration Research	000	2	7/19/2019	NON-COMPETING CONTINUATION	$299,474
														Subtotal = $299,474

Issue Date FY: 2018 ( Subtotal = $299,224 )
2018	2018	THE CHILDRENS HOSPITAL LOS ANGELES	4650 W SUNSET BLVD	LOS ANGELES	CA	90027	LOS ANGELES	USA	Food and Drug Administration Research	001	1	8/29/2018	NEW	$0
2018	2018	THE CHILDRENS HOSPITAL LOS ANGELES	4650 W SUNSET BLVD	LOS ANGELES	CA	90027	LOS ANGELES	USA	Food and Drug Administration Research	000	1	8/28/2018	NEW	$299,224
														Subtotal = $299,224

Grand Total All Awards = $895,721

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PBPK and Population Modeling Seamlessly Linked to Clinical Trial Simulation in an Open-Source Software Platform

Award Number: U01FD006549

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

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