Throckmorton DC
How a US regulator can encourage new science. [Comment, Journal Article]
Clin Pharmacol Ther 2009 Nov; 86(5):471-2.
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.
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