Serum chemical biomarkers of cardiac injury for nonclinical safety testing.

Abstract:

:There has been a substantial increase in the number and efficacy of laboratory biomarkers for the evaluation of human cardiac injury over the last decade. The advantages of these over traditional laboratory tests have encouraged adoption of comparable markers in nonclinical studies for cardiac injury assessment. Of particular interest are markers that are not only more sensitive and/or specific than traditional parameters for cardiac injury, but also those that may directly bridge human and laboratory animal safety testing. However, a majority of recently developed markers are quantified through antibody-based assays, and cross-reactivity with the comparable analyte in nonhuman samples is difficult to predict and often species-variable. The utility of these novel biomarkers thus, depends upon adequate assay validation with each laboratory species of interest. In contrast, traditional laboratory parameters of cardiac injury lack the properties of an ideal biomarker, but are well established and have an extensive database in nonclinical safety assessment. The current status and utility of both recently developed and traditional biomarkers of cardiac injury in nonclinical testing, and considerations for validation of novel biomarkers of cardiac injury are reviewed.

journal_name

Toxicol Pathol

journal_title

Toxicologic pathology

authors

Walker DB

doi

10.1080/01926230500519816

subject

Has Abstract

pub_date

2006-01-01 00:00:00

pages

94-104

issue

1

eissn

0192-6233

issn

1533-1601

pii

R13R5N7025270203

journal_volume

34

pub_type

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