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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.
Strategy for genotoxicity testing: hazard identification and risk assessment in relation to in vitro testing.
Thybaud V, Aardema M, Clements J, Dearfield K, Galloway S, Hayashi M, Jacobson-Kram D, Kirkland D, MacGregor JT, Marzin D, Ohyama W, Schuler M, Suzuki H, Zeiger E; Expert Working Group on Hazard Identification and Risk Assessment in Relation to In Vitro Testing. Thybaud V, et al. Mutat Res. 2007 Feb 3;627(1):41-58. doi: 10.1016/j.mrgentox.2006.10.003. Epub 2006 Nov 27. Mutat Res. 2007. PMID: 17126066
Genetic toxicology assessment of HI-6 dichloride.
Putman D, San RH, Bigger CA, Levine BS, Jacobson-Kram D. Putman D, et al. Environ Mol Mutagen. 1996;27(2):152-61. doi: 10.1002/(SICI)1098-2280(1996)27:2<152::AID-EM9>3.0.CO;2-I. Environ Mol Mutagen. 1996. PMID: 8603667
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.
Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact.
Goodsaid FM, Amur S, Aubrecht J, Burczynski ME, Carl K, Catalano J, Charlab R, Close S, Cornu-Artis C, Essioux L, Fornace AJ Jr, Hinman L, Hong H, Hunt I, Jacobson-Kram D, Jawaid A, Laurie D, Lesko L, Li HH, Lindpaintner K, Mayne J, Morrow P, Papaluca-Amati M, Robison TW, Roth J, Schuppe-Koistinen I, Shi L, Spleiss O, Tong W, Truter SL, Vonderscher J, Westelinck A, Zhang L, Zineh I. Goodsaid FM, et al. Nat Rev Drug Discov. 2010 Jun;9(6):435-45. doi: 10.1038/nrd3116. Nat Rev Drug Discov. 2010. PMID: 20514070 Review.
Review of the mutagenicity of ethylene oxide.
Dellarco VL, Generoso WM, Sega GA, Fowle JR 3rd, Jacobson-Kram D. Dellarco VL, et al. Environ Mol Mutagen. 1990;16(2):85-103. doi: 10.1002/em.2850160207. Environ Mol Mutagen. 1990. PMID: 2209569 Review.
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