Development and validation of a multi-analyte profile (MAP) of putative biomarkers of human kidney damage

Introduction In June 2008, the FDA and EMEA issued a joint framework allowing submission of a single application for 7 new urinary biomarkers of drug-induced kidney damage in rats. Based on our previous experience in developing both assays and analyzing samples for Novartis as part of the FDA/EMEA submission by the C-Path Predictive Safety Testing Consortium (PSTC), we sought to develop and validate a human kidney Multi-Analyte Profile (MAP) corresponding to the 7 rat biomarkers in addition to several other analytes that based on published reports may have utility as biomarkers of human kidney damage. The validated panel of human analytes will be useful for human and non-human primate studies designed to advance the qualification of biomarkers of drug induced kidney damage.