Zobrazeno 1 - 10
of 13
pro vyhledávání: '"Elizabeth G. Walker"'
Publikováno v:
BMC Public Health, Vol 22, Iss 1, Pp 1-12 (2022)
Abstract Background Extreme, prolonged wildfire smoke (WFS) events are becoming increasingly frequent phenomena across the Western United States. Rural communities, dependent on contributions of nature to people’s quality of life, are particularly
Externí odkaz:
https://doaj.org/article/7735ed001343450aa1326194a40e4385
Autor:
Elizabeth G. Walker, Ernie Harpur
Publikováno v:
Current Opinion in Toxicology. 4:66-73
There are multiple categories of biomarkers (such as safety, diagnostic, prognostic, susceptibility/risk, predictive, monitoring, pharmacodynamic/response or surrogate) giving rise to many applications in clinical medicine and drug development. The s
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::55115b6d08db04d8dd8c67967c30b7ec
https://doi.org/10.1016/j.cotox.2017.06.011
https://doi.org/10.1016/j.cotox.2017.06.011
Publikováno v:
Therapeutic innovationregulatory science. 48(2)
Regulatory science, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of regulated medical products, has advanced over time due to a number of factors. The FDA, the EMA, and the Ph
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6735e75747cfba35557902b2240804e3
https://pubmed.ncbi.nlm.nih.gov/30227514
https://pubmed.ncbi.nlm.nih.gov/30227514
Publikováno v:
Drug Development Research. 74:112-126
Preclinical Research Biomarkers hold tremendous promise to improve the drug development and evaluation process, advance patient care, and reduce health-care costs. However, understanding the characteristics of novel biomarkers and developing the robu
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f2b82ec84ee018746f6239c38d6e193e
https://doi.org/10.1002/ddr.21070
https://doi.org/10.1002/ddr.21070
Autor:
Jonathan A. Phillips, Peter M. Burch, Warren E. Glaab, Daniel J. Holder, John-Michael Sauer, Elizabeth G. Walker
Publikováno v:
Toxicological sciences : an official journal of the Society of Toxicology. 156(1)
One of the goals of the Critical Path Institute's Predictive Safety Testing Consortium (PSTC) is to promote best practices for evaluating novel markers of drug induced injury. This includes the use of sound statistical methods. For rat studies, these
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f95393e798f04b29d556d5b9a07b2fad
https://pubmed.ncbi.nlm.nih.gov/27815493
https://pubmed.ncbi.nlm.nih.gov/27815493
Autor:
Elizabeth G. Walker, Daniela Ennulat, Diane Hamlin, Yi Yang, Karen M. Lynch, Manisha Sonee, Sean P. Troth, Dominique Brees, John-Michael Sauer, Jonathan A. Phillips, Jean-Charles Gautier, David Peters, Yi-Zhong Gu, J. Eric McDuffie, Daniel J. Holder
Publikováno v:
Toxicological sciences : an official journal of the Society of Toxicology. 151(2)
Traditional kidney biomarkers are insensitive indicators of acute kidney injury, with meaningful changes occurring late in the course of injury. The aim of this work was to demonstrate the diagnostic potential of urinary osteopontin (OPN) and neutrop
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5324942cbd924efcbe077cb0ea1cc24c
https://pubmed.ncbi.nlm.nih.gov/27026710
https://pubmed.ncbi.nlm.nih.gov/27026710
Publikováno v:
Drug Discovery Toxicology
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::97013ce56d5323c0b7f46c3449d79061
https://doi.org/10.1002/9781119053248.ch44
https://doi.org/10.1002/9781119053248.ch44
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
https://doi.org/10.1038/nbt.1625
Publikováno v:
Journal of Medicines Development Sciences. 1:34
The Predictive Safety Testing Consortium (PSTC) is one of nine consortia comprising the Critical Path Institute (C-Path), a non-profit organisation launched in 2005 and dedicated to playing the role of a catalyst in the development of new approaches
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::da9747bf01463cbdf38c7f548ccdb7b2
https://doi.org/10.18063/jmds.v1i1.116
https://doi.org/10.18063/jmds.v1i1.116
Autor:
Ernie Harpur, Yan Yu, Peter L. Goering, David Gerhold, Valerie Guilpin, Jacky Vonderscher, Frank Dieterle, Marisa Papaluca-Amati, Matthew J. Schipper, Jean Marc Vidal, Gerard Maurer, Federico Goodsaid, William B. Mattes, Peter Kasper, Yi Zhong Gu, David Laurie, Dina Andrews-Cleavenger, Alita Hassan, Romaldas Mačiulaitis, Nathaniel Collins, Elizabeth G. Walker, William Baer, Josef S. Ozer, Jonathan A. Phillips, Spiros Vamvakas, Frank D. Sistare, Karol L. Thompson, David Jacobson-Kram, Beatriz Silva Lima, Daniel J. Holder, Denise Bounous, Graham Betton, Craig P. Webb, Kevin Carl, Mark Pinches, Leslie A. Obert, Sean P. Troth
Publikováno v:
Nature biotechnology. 28(5)
Application of any new biomarker to support safety-related decisions during regulated phases of drug development requires provision of a substantial data set that critically assesses analytical and biological performance of that biomarker. Such an ap
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4e8019fe31787b5c08d6073a8291f662
https://pubmed.ncbi.nlm.nih.gov/20458314
https://pubmed.ncbi.nlm.nih.gov/20458314