Novel Biomarkers of Acute Kidney Toxicity

被引：30

作者：

Goodsaid, F. M. ^{[1
]}

Blank, M. ^{[2
]}

Dieterle, F. ^{[3
]}

Harlow, P. ^{[2
]}

Hausner, E. ^{[2
]}

Sistare, F. ^{[4
]}

Thompson, A. ^{[2
]}

Vonderscher, J. ^{[5
]}

机构：

[1] US FDA, Genom Grp, Off Clin Pharmacol, Off Translat Sci,Ctr Drug Evaluat & Res, Silver Spring, MD USA

[2] Ctr Drug Evaluat & Res, Div Cardiovasc & Renal Prod, Off New Drugs, Silver Spring, MD USA

[3] Novartis Pharma AG, Novartis Inst BioMed Res, Translat Sci, Basel, Switzerland

[4] Merck, Safety Assessment, Lab Sci & Investigat Toxicol, West Point, PA USA

[5] Roche, PDL, Basel, Switzerland

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2009年 / 86卷 / 05期

关键词：

INJURY MOLECULE-1 KIM-1; PROXIMAL TUBULE INJURY; ACUTE-RENAL-FAILURE; INDUCED NEPHROTOXICITY; URINARY BIOMARKER; DRUG DEVELOPMENT; EXPRESSION; IDENTIFICATION; GENTAMICIN; RATS;

D O I：

10.1038/clpt.2009.149

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Novel biomarkers of kidney toxicity are powerful tools not only with respect to their clinical applications but also because of their impact on drug development. These biomarkers can influence the assessment of efficacy of new drugs for kidney diseases as well as the risk management for new drugs. The science behind these novel biomarkers reflects the evolution over the past decade of genomic and proteomic platforms that have transformed the discovery and development of new biomarkers for preclinical and clinical applications in drug development. Several of these biomarkers are in use as transcriptomic biomarkers in animal models as well as translational proteomic biomarkers in animal models and in humans. Their ability to detect kidney damage earlier than is possible with currently accessible biomarkers is being given qualification through regulatory biomarker-qualification programs, which will help establish consensus for their widespread use.

引用

页码：490 / 496

页数：7

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