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Sample Collection and Analysis to Expand Demographics Diversity of Reference Range for the Final Qualification Package for GLDH Activity as a Biomarker of Drug Induced Liver Injury (DDT-BMQ-000050)

Award Number: U01FD007464
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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ABSTRACT This project seeks to increase our understanding of the normal reference range of glutamate dehydrogenase (GLDH) in pediatric, geriatric, and expanded ethnic normal healthy populations, which will address an unmet need in drug development for detecting and monitoring drug-induced liver injury (DILI). The evidence generated by this project is necessary to support the qualification of GLDH by the Food and Drug Administration’s (FDA’s) Biomarker Qualification Program (BQP). This qualification effort is being led by the Predictive Safety Testing Consortium’s Hepatotoxicity Working Group, for which GLDH as a safety biomarker to detect DILI was into the Biomarker Qualification Program. In order to progress to the next stage of qualification, the Hepatotoxicity Working Group must prepare a Final Qualification Package which summarizes the performance of GLDH in the confirmatory studies to support the proposed context of use under consideration by the Biomarker Qualification Program. To date, the Hepatotoxicity Working Group has not defined the normal reference range of GLDH in these populations, nor has it been found in the published literature. To address this gap, the Critical Path Institute (C-Path) proposes the following research aims. Specific Aim 1 will conduct a study to collect samples from healthy individuals spanning additional age groups under-represented in the original studies in 100 normal healthy volunteers (both male and female; 50 pediatric and 50 geriatric), from the United States (US). The study will collect single samples from subjects at the University of Michigan Hospital for routine visits. In addition, Specific Aim 2 is to conduct a study to collect samples from healthy individuals to expand ethnicities under-represented in the original studies, which will support the future submission of a Qualification Plan for DDT# DDTBMQ000050 in order to further the understanding of GLDH in various populations.


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 = -$2,424 )
2024	2021	THE CRITICAL PATH INSTITUTE	1840 E RIVER RD	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	000	1	4/29/2024	NEW	-$2,424
														Subtotal = -$2,424

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	001	1	7/8/2022	NEW	$0
2022	2021	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	000	1	6/27/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $247,269 )
2021	2021	CRITICAL PATH INSTITUTE, THE	1730 E RIVER RD STE 200	TUCSON	AZ	85718	PIMA	USA	Food and Drug Administration Research	000	1	8/17/2021	NEW	$247,269
														Subtotal = $247,269

Grand Total All Awards = $244,845

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Sample Collection and Analysis to Expand Demographics Diversity of Reference Range for the Final Qualification Package for GLDH Activity as a Biomarker of Drug Induced Liver Injury (DDT-BMQ-000050)

Award Number: U01FD007464

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

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