How a US regulator can encourage new science.
The Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA) is developing a process to qualify biomarkers for use under particular conditions. As part of this effort, Goodsaid et al. have carried out work, described in this issue, on the formal qualification of novel biomarkers of acute renal toxicity in animals. The authors' experiences highlight the importance of collaboration and the role of regulators.
Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. douglas.throckmorton@fda.hhs.gov
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D058186:Acute Kidney Injury / Q000139:chemically induced / Q000503:physiopathology*; D000818:Animals; D015415:Biomarkers / Q000032:analysis*; D015195:Drug Design; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007880:Legislation, Drug; D023421:Models, Animal; D014481:United States; D014486:United States Food and Drug Administration
D015415:Biomarkers