New Preclinical Biomarkers Of Nephrotoxiciy

In recent years, two consortia led by the nonprofit organizations ILSI-HESI (International Life Sciences Institute, Health and Environmental Sciences Institute, http://www.hesiglobal.org) and C-Path (Critical Path Institute, http:// www.c-path.org) aligned with leaders in academia, industry, and the FDA with a mission to evaluate the potential utility of newly identified biomarkers of nephrotoxicity for use in preclinical safety studies and to develop a process for the acceptance of the new biomarkers in support of safety data accompanying new regulatory submissions. Several criteria for the evaluation and development of new biomarkers of nephrotoxicity were considered, including:

TABLE 2 Biomarkers of Renal Injury by Region of Specificity, Onset, Platform, and Application

Biomarker

Injury Related to:

Onset

Platforms

Application

ß2-Microglobulin

Proximal tubular

Early

Luminex,

Mouse, rat, human,

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Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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