A roadmap for biomarker qualification.Comments Comment on: Nat Biotechnol. 2010 May;28(5):478-85; PMID: 20458318, Comment on: Nat Biotechnol. 2010 May;28(5):463-9; PMID: 20458316, Comment on: Nat Biotechnol. 2010 May;28(5):470-7; PMID: 20458317, Comment on: Nat Biotechnol. 2010 May;28(5):486-94; PMID: 20458319

摘要

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. The dependence of preclinical screens on histopathology and weakly informative biomarkers causes considerable delays and inefficiency in transitioning new drugs into human testing. This delays confirmation of the safety and effectiveness of new therapies. Four papers1, 2, 3, 4 in this issue describe the utility of previously described markers of kidney damage to specifically assess renal damage in rats exposed to a range of nephrotoxic agents. Two additional manuscripts5, 6 further describe the protocols used to qualify these biomarkers and explain the broader implications of the assessments issued by two major regulatory bodies, the Food and Drug Administration (FDA) and European Medicines Agency (EMEA; London). Together, the papers document progress toward establishing a formal process that will hopefully emerge as a model for developing better biomarkers for predicting a range of toxicities frequently encountered during drug development.