Premium
How a US Regulator Can Encourage New Science
Author(s) -
Throckmorton DC
Publication year - 2009
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2009.188
Subject(s) - clinical pharmacology , food and drug administration , regulatory science , pharmacology , engineering ethics , medicine , engineering , pathology
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. Clinical Pharmacology & Therapeutics (2009) 86 5, 471–472. doi: 10.1038/clpt.2009.188