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Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials.
Sewell F, Chapman K, Baldrick P, Brewster D, Broadmeadow A, Brown P, Burns-Naas LA, Clarke J, Constan A, Couch J, Czupalla O, Danks A, DeGeorge J, de Haan L, Hettinger K, Hill M, Festag M, Jacobs A, Jacobson-Kram D, Kopytek S, Lorenz H, Moesgaard SG, Moore E, Pasanen M, Perry R, Ragan I, Robinson S, Schmitt PM, Short B, Lima BS, Smith D, Sparrow S, van Bekkum Y, Jones D. Sewell F, et al. Among authors: jacobson kram d. Regul Toxicol Pharmacol. 2014 Oct;70(1):413-29. doi: 10.1016/j.yrtph.2014.07.018. Epub 2014 Jul 29. Regul Toxicol Pharmacol. 2014. PMID: 25078890 Free article.
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. Nat Biotechnol. 2010 May;28(5):455-62. doi: 10.1038/nbt.1625. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458315
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. Nat Biotechnol. 2010 May;28(5):446-54. doi: 10.1038/nbt.1634. Epub 2010 May 10. Nat Biotechnol. 2010. PMID: 20458314
A critical review of the acetaminophen preclinical carcinogenicity and tumor promotion data and their implications for its carcinogenic hazard potential.
Murray FJ, Monnot AD, Jacobson-Kram D, Cohen SM, Hardisty JF, Bandara SB, Kovochich M, Deore M, Pitchaiyan SK, Gelotte CK, Lai JCK, Atillasoy E, Hermanowski-Vosatka A, Kuffner E, Unice KM, Yang K, Gebremichael Y, Howell BA, Eichenbaum G. Murray FJ, et al. Among authors: jacobson kram d. Regul Toxicol Pharmacol. 2020 Dec;118:104801. doi: 10.1016/j.yrtph.2020.104801. Epub 2020 Oct 9. Regul Toxicol Pharmacol. 2020. PMID: 33039518 Free article. Review.
A comprehensive weight of evidence assessment of published acetaminophen genotoxicity data: Implications for its carcinogenic hazard potential.
Kirkland D, Kovochich M, More SL, Murray FJ, Monnot AD, Miller JV, Jaeschke H, Jacobson-Kram D, Deore M, Pitchaiyan SK, Unice K, Eichenbaum G. Kirkland D, et al. Among authors: jacobson kram d. Regul Toxicol Pharmacol. 2021 Jun;122:104892. doi: 10.1016/j.yrtph.2021.104892. Epub 2021 Feb 13. Regul Toxicol Pharmacol. 2021. PMID: 33592196 Free article. Review.
New and emerging technologies for genetic toxicity testing.
Lynch AM, Sasaki JC, Elespuru R, Jacobson-Kram D, Thybaud V, De Boeck M, Aardema MJ, Aubrecht J, Benz RD, Dertinger SD, Douglas GR, White PA, Escobar PA, Fornace A Jr, Honma M, Naven RT, Rusling JF, Schiestl RH, Walmsley RM, Yamamura E, van Benthem J, Kim JH. Lynch AM, et al. Environ Mol Mutagen. 2011 Apr;52(3):205-23. doi: 10.1002/em.20614. Epub 2010 Aug 25. Environ Mol Mutagen. 2011. PMID: 20740635 Review.
88 results