title: Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium.
abstract: The first formal qualification of safety biomarkers for regulatory decision making marks a milestone in the application of biomarkers to drug development. Following submission of drug toxicity studies and analyses of biomarker performance to the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) by the Predictive Safety Testing Consortium's (PSTC) Nephrotoxicity Working Group, seven renal safety biomarkers have been qualified for limited use in nonclinical and clinical drug development to help guide safety assessments. This was a pilot process, and the experience gained will both facilitate better understanding of how the qualification process will probably evolve and clarify the minimal requirements necessary to evaluate the performance of biomarkers of organ injury within specific contexts.
authors.affiliation: Novartis Pharma AG, Basel, Switzerland. frank.dieterle@novartis.com
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authors.lastname: Akunda
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authors.lastname: Obert
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authors.lastname: Snook
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mesh_terms: D000818:Animals; D054316:Biomarkers, Pharmacological; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D006801:Humans; D007668:Kidney / Q000187:drug effects / Q000293:injuries; D004364:Pharmaceutical Preparations / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D054316:Biomarkers, Pharmacological; D004364:Pharmaceutical Preparations
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