Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2010 May;28(5):455-62.
doi: 10.1038/nbt.1625. Epub 2010 May 10.

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

Frank Dieterle  1 , Frank Sistare, Federico Goodsaid, Marisa Papaluca, Josef S Ozer, Craig P Webb, William Baer, Anthony Senagore, Matthew J Schipper, Jacky Vonderscher, Stefan Sultana, David L Gerhold, Jonathan A Phillips, Gérard Maurer, Kevin Carl, David Laurie, Ernie Harpur, Manisha Sonee, Daniela Ennulat, Dan Holder, Dina Andrews-Cleavenger, Yi-Zhong Gu, Karol L Thompson, Peter L Goering, Jean-Marc Vidal, Eric Abadie, Romaldas Maciulaitis, David Jacobson-Kram, Albert F Defelice, Elizabeth A Hausner, Melanie Blank, Aliza Thompson, Patricia Harlow, Douglas Throckmorton, Shen Xiao, Nancy Xu, William Taylor, Spiros Vamvakas, Bruno Flamion, Beatriz Silva Lima, Peter Kasper, Markku Pasanen, Krishna Prasad, Sean Troth, Denise Bounous, Denise Robinson-Gravatt, Graham Betton, Myrtle A Davis, Jackie Akunda, James Eric McDuffie, Laura Suter, Leslie Obert, Magalie Guffroy, Mark Pinches, Supriya Jayadev, Eric A Blomme, Sven A Beushausen, Valérie G Barlow, Nathaniel Collins, Jeff Waring, David Honor, Sandra Snook, Jinhe Lee, Phil Rossi, Elizabeth Walker, William Mattes
Affiliations

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

Frank Dieterle et al. Nat Biotechnol. 2010 May.

Abstract

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.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Nat Biotechnol. 2010 May;28(5):463-9 - PubMed
    1. Nat Biotechnol. 2010 May;28(5):486-94 - PubMed
    1. Pharm Res. 2006 Feb;23(2):312-28 - PubMed
    1. Shock. 2006 Sep;26(3):245-53 - PubMed
    1. Nat Biotechnol. 2010 May;28(5):446-54 - PubMed

Substances

LinkOut - more resources