# 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)

> **NIH FDA U01** · CRITICAL PATH INSTITUTE · 2021 · $247,269

## Abstract

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.

## Key facts

- **NIH application ID:** 10411701
- **Project number:** 1U01FD007464-01
- **Recipient organization:** CRITICAL PATH INSTITUTE
- **Principal Investigator:** Nicholas King
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2021
- **Award amount:** $247,269
- **Award type:** 1
- **Project period:** 2021-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10411701

## Citation

> US National Institutes of Health, RePORTER application 10411701, 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) (1U01FD007464-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10411701. Licensed CC0.

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