Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium
Frank Dieterle(Novartis (Switzerland)), Frank D. Sistare(United States Military Academy), Federico Goodsaid(United States Food and Drug Administration), Marisa Papaluca, Josef Ozer(United States Military Academy), Craig P. Webb(Van Andel Institute), William Baer(Retina Specialists of Michigan), Anthony J. Senagore(Spectrum Health), Matthew J. Schipper(EP Analytics (United States)), Jacky Vonderscher(Roche (Switzerland)), Stefan Sultana, David Gerhold(United States Military Academy), Jonathan A. Phillips(Boehringer Ingelheim (United States)), Gerald Maurer(Novartis (Switzerland)), Kevin Carl(Novartis (Switzerland)), David Laurie(Novartis (Switzerland)), Ernie Harpur(Sanofi (United States)), Manisha Sonee(Johnson & Johnson (United States)), Daniela Ennulat(GlaxoSmithKline (United States)), Dan Holder(United States Military Academy), Dina Andrews-Cleavenger(Amgen (United States)), Yi-Zhong Gu, Karol L. Thompson(United States Food and Drug Administration), Peter L. Goering(United States Food and Drug Administration), Jean-Marc Vidal, Éric Abadie, Romaldas Mačiulaitis(Hospital of Lithuanian University of Health Sciences Kaunas Clinics), David Jacobson‐Kram(United States Food and Drug Administration), Albert DeFelice(United States Food and Drug Administration), Elizabeth A. Hausner(United States Food and Drug Administration), Melanie Blank(United States Food and Drug Administration), Aliza Thompson(United States Food and Drug Administration), Patricia Harlow(United States Food and Drug Administration), Douglas C. Throckmorton(United States Food and Drug Administration), Shen Xiao(United States Food and Drug Administration), Nancy Xu(United States Food and Drug Administration), William Taylor(United States Food and Drug Administration), Spiros Vamvakas, Bruno Flamion, Beatriz Silva Lima, Peter Kasper, Markku Pasanen(University of Eastern Finland), Kushal Prasad, Sean P. Troth(United States Military Academy), Denise I. Bounous(Bristol-Myers Squibb (United States)), Denise Robinson-Gravatt(Pfizer (United States)), Graham R. Betton(AstraZeneca (United Kingdom)), Myrtle A. Davis(National Institutes of Health), Jackie Akunda(Eli Lilly (United States)), J. Eric McDuffie(Johnson & Johnson (United States)), Laura Suter‐Dick(Roche (Switzerland)), Leslie Obert(Pfizer (United States)), Magalie Guffroy(Sanofi (United States)), Mark Pinches(AstraZeneca (United Kingdom)), Supriya Jayadev(Boehringer Ingelheim (United States)), Eric A.G. Blomme(Abbott Fund), Sven Beushausen(Pfizer (United States)), Valerie G. Barlow(Sanofi (United States)), Nathaniel D. Collins, Jeff Waring(Abbott Fund), David J. Honor(Abbott Fund), Sandra S. Snook(Johnson & Johnson (United States)), Jinhe Lee(Abbott Fund), Phil Rossi(Critical Path Institute), Elizabeth G. Walker(Critical Path Institute), William B. Mattes(Critical Path Institute)
Cited by 405
Abstract
Related Papers
No related papers found
Powered by citation graph analysis