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

Frank Dieterle, 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 HolderDina 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

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