title: Preclinical perspective of urinary biomarkers for the detection of nephrotoxicity: what we know and what we need to know.
abstract: The assessment of kidney damage is a challenge and must incorporate assessment of the functional capacity of the kidney, as well as a comprehensive understanding of the kidney's role. Multiple parameters have been used for many years to measure renal functionality to assess renal damage. It is astonishing that, beside histopathology, the most common traditional parameters are serum based. However, urine is also used to obtain additional information regarding the health status of the kidneys. Since 2008, several novel urinary protein biomarkers have been qualified by the US FDA and the European Medicines Agency in conjunction with the Predictive Safety Testing Consortium in a specially developed qualification process. Subsequently, the Pharmaceuticals and Medical Devices Agency accepted the qualification of these seven urinary biomarkers. This review will give an overview of the state-of-the-art detection based on urinary biomarkers, which will enhance toxicological research in the future. In addition, the qualification process that leads to acceptance of these biomarkers will be described because of its uniqueness and importance for the field of biomarker research.
authors: Toxicology, Merck Serono, Frankfurter Strasse 250, Darmstadt, Germany.
authors: Tobias Christian
authors: TC
authors: Fuchs
authors: Philip
authors: P
authors: Hewitt
mesh_terms: D058186:Acute Kidney Injury / Q000209:etiology / Q000652:urine*; D000818:Animals; D015415:Biomarkers / Q000652:urine*; D004353:Drug Evaluation, Preclinical; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007668:Kidney / Q000187:drug effects* / Q000201:enzymology / Q000378:metabolism
chemical_list: D015415:Biomarkers