A roadmap for biomarker qualification

• Published in: Nature biotechnology Vol. 28; no. 5; pp. 444 - 445
• Main Authors: Warnock, David G, Peck, Carl C
• Format: Journal Article
• Language: English
• Published: New York Nature Publishing Group US 01.05.2010; Nature Publishing Group
• Subjects: 631/154/1438; 631/154/2426/2145; 631/154/53; 692/308/2778; Agriculture; Animals; Bioinformatics; Biomarkers; Biomarkers, Pharmacological; Biomedical and Life Sciences; Biomedical Engineering/Biotechnology; Biomedicine; Biotechnology; Collaboration; Drug-Related Side Effects and Adverse Reactions; Humans; Kidney - drug effects; Kidney - injuries; Kidney diseases; Life Sciences; Medical research; news-and-views; Pharmaceutical industry; Pharmaceutical Preparations - standards; Toxicity; Toxicity Tests - standards; United States; United States Food and Drug Administration; United States

A collaborative effort between pharmaceutical companies, regulatory agencies and academia to qualify biomarkers for kidney toxicity provides a model for investigating and identifying reliable safety markers for preclinical applications.