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

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

Publikováno v: Nature Biotechnology. 28:455-462

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

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::153a6b13ac5e7fb2e36ce91685f63c53
https://doi.org/10.1038/nbt.1625

Biomarker Qualification – Past, Present and Future

Autor: Raegan O’Lone, Syril D Pettit, Denise Robinson-Gravatt, Jiri Aubrecht

Against the backdrop of the launch of the Human Genome Project, scientists from a variety of industries, academia and governmental organizations convened in late 1998 under the sponsorship of the International Life Sciences Institute (ILSI) Health an

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::27b7216806162a2b683458339c0277f2
https://doi.org/10.1016/b978-0-12-391496-5.00012-0