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Page 1
Towards consensus practices to qualify safety biomarkers for use in early drug development.
Sistare FD, Dieterle F, Troth S, Holder DJ, Gerhold D, Andrews-Cleavenger D, Baer W, Betton G, Bounous D, Carl K, Collins N, Goering P, Goodsaid F, Gu YZ, Guilpin V, Harpur E, Hassan A, Jacobson-Kram D, Kasper P, Laurie D, Lima BS, Maciulaitis R, Mattes W, Maurer G, Obert LA, Ozer J, Papaluca-Amati M, Phillips JA, Pinches M, Schipper MJ, Thompson KL, Vamvakas S, Vidal JM, Vonderscher J, Walker E, Webb C, Yu Y. Sistare FD, et al. Among authors: walker e. Nat Biotechnol. 2010 May;28(5):446-54. doi: 10.1038/nbt.1634. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458314
Research at the interface of industry, academia and regulatory science.
Mattes WB, Walker EG, Abadie E, Sistare FD, Vonderscher J, Woodcock J, Woosley RL. Mattes WB, et al. Among authors: walker eg. Nat Biotechnol. 2010 May;28(5):432-3. doi: 10.1038/nbt0510-432. Nat Biotechnol. 2010. PMID: 20458309 No abstract available.
Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium.
Dieterle F, Sistare F, Goodsaid F, Papaluca M, Ozer JS, Webb CP, Baer W, Senagore A, Schipper MJ, Vonderscher J, Sultana S, Gerhold DL, Phillips JA, Maurer G, Carl K, Laurie D, Harpur E, Sonee M, Ennulat D, Holder D, Andrews-Cleavenger D, Gu YZ, Thompson KL, Goering PL, Vidal JM, Abadie E, Maciulaitis R, Jacobson-Kram D, Defelice AF, Hausner EA, Blank M, Thompson A, Harlow P, Throckmorton D, Xiao S, Xu N, Taylor W, Vamvakas S, Flamion B, Lima BS, Kasper P, Pasanen M, Prasad K, Troth S, Bounous D, Robinson-Gravatt D, Betton G, Davis MA, Akunda J, McDuffie JE, Suter L, Obert L, Guffroy M, Pinches M, Jayadev S, Blomme EA, Beushausen SA, Barlow VG, Collins N, Waring J, Honor D, Snook S, Lee J, Rossi P, Walker E, Mattes W. Dieterle F, et al. Among authors: walker e. Nat Biotechnol. 2010 May;28(5):455-62. doi: 10.1038/nbt.1625. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458315
Evaluation of the Relative Performance of Drug-Induced Skeletal Muscle Injury Biomarkers in Rats.
Burch PM, Greg Hall D, Walker EG, Bracken W, Giovanelli R, Goldstein R, Higgs RE, King NM, Lane P, Sauer JM, Michna L, Muniappa N, Pritt ML, Vlasakova K, Watson DE, Wescott D, Zabka TS, Glaab WE. Burch PM, et al. Among authors: walker eg. Toxicol Sci. 2016 Mar;150(1):247-56. doi: 10.1093/toxsci/kfv328. Epub 2015 Dec 31. Toxicol Sci. 2016. PMID: 26721300
Novel coenzyme Q6 genetic variant increases susceptibility to pneumococcal disease.
Walker EC, Javati S, Todd EM, Matlam JP, Lin X, Bryant M, Krone E, Ramani R, Chandra P, Green TP, Anaya EP, Zhou JY, Alexander KA, Tong RS, Yuasi L, Boluarte S, Yang F, Greenberg L, Nerbonne JM, Greenberg MJ, Clemens RA, Philips JA, Wilson LD, Halabi CM, DeBosch BJ, Blyth CC, Druley TE, Kazura JW, Pomat WS, Morley SC. Walker EC, et al. Nat Immunol. 2024 Nov 4. doi: 10.1038/s41590-024-01998-4. Online ahead of print. Nat Immunol. 2024. PMID: 39496954
2,902 results