Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

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 Medici...

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Published in:Nature biotechnology 2010-05, Vol.28 (5), p.455-462
Main Authors: Dieterle, Frank, Sistare, Frank, Goodsaid, Federico, Papaluca, Marisa, Ozer, Josef S, Webb, Craig P, Baer, William, Senagore, Anthony, Schipper, Matthew J, Vonderscher, Jacky, Sultana, Stefan, Gerhold, David L, Phillips, Jonathan A, Maurer, Gérard, Carl, Kevin, Laurie, David, Harpur, Ernie, Sonee, Manisha, Ennulat, Daniela, Holder, Dan, Andrews-Cleavenger, Dina, Gu, Yi-Zhong, Thompson, Karol L, Goering, Peter L, Vidal, Jean-Marc, Abadie, Eric, Maciulaitis, Romaldas, Jacobson-Kram, David, Defelice, Albert F, Hausner, Elizabeth A, Blank, Melanie, Thompson, Aliza, Harlow, Patricia, Throckmorton, Douglas, Xiao, Shen, Xu, Nancy, Taylor, William, Vamvakas, Spiros, Flamion, Bruno, Lima, Beatriz Silva, Kasper, Peter, Pasanen, Markku, Prasad, Krishna, Troth, Sean, Bounous, Denise, Robinson-Gravatt, Denise, Betton, Graham, Davis, Myrtle A, Akunda, Jackie, McDuffie, James Eric, Suter, Laura, Obert, Leslie, Guffroy, Magalie, Pinches, Mark, Jayadev, Supriya, Blomme, Eric A, Beushausen, Sven A, Barlow, Valérie G, Collins, Nathaniel, Waring, Jeff, Honor, David, Snook, Sandra, Lee, Jinhe, Rossi, Phil, Walker, Elizabeth, Mattes, William
Format: Article
Language:English
Subjects:
Animals
Biological markers
Biomarkers
Biomarkers, Pharmacological
Care and treatment
Diagnosis
Drug Approval - legislation & jurisprudence
Drug-Related Side Effects and Adverse Reactions
Europe
Federal regulation
Humans
Kidney - drug effects
Kidney - injuries
Kidney diseases
Patient safety
Pharmaceutical industry
Pharmaceutical Preparations - standards
United States
United States Food and Drug Administration
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Summary: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.
ISSN:1087-0156
1546-1696
DOI:10.1038/nbt.1625