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A framework to assess the translation of safety pharmacology data to humans.
Valentin JP, Bialecki R, Ewart L, Hammond T, Leishmann D, Lindgren S, Martinez V, Pollard C, Redfern W, Wallis R. Valentin JP, et al. Among authors: ewart l. J Pharmacol Toxicol Methods. 2009 Sep-Oct;60(2):152-8. doi: 10.1016/j.vascn.2009.05.011. Epub 2009 Jul 17. J Pharmacol Toxicol Methods. 2009. PMID: 19616110
How do the top 12 pharmaceutical companies operate safety pharmacology?
Ewart L, Gallacher DJ, Gintant G, Guillon JM, Leishman D, Levesque P, McMahon N, Mylecraine L, Sanders M, Suter W, Wallis R, Valentin JP. Ewart L, et al. J Pharmacol Toxicol Methods. 2012 Sep;66(2):66-70. doi: 10.1016/j.vascn.2012.03.004. Epub 2012 Apr 1. J Pharmacol Toxicol Methods. 2012. PMID: 22510338
A multi-site comparison of in vivo safety pharmacology studies conducted to support ICH S7A & B regulatory submissions.
Ewart L, Milne A, Adkins D, Benjamin A, Bialecki R, Chen Y, Ericsson AC, Gardner S, Grant C, Lengel D, Lindgren S, Lowing S, Marks L, Moors J, Oldman K, Pietras M, Prior H, Punton J, Redfern WS, Salmond R, Skinner M, Some M, Stanton A, Swedberg M, Finch J, Valentin JP. Ewart L, et al. J Pharmacol Toxicol Methods. 2013 Jul-Aug;68(1):30-43. doi: 10.1016/j.vascn.2013.04.008. Epub 2013 May 9. J Pharmacol Toxicol Methods. 2013. PMID: 23665080
The concordance between nonclinical and phase I clinical cardiovascular assessment from a cross-company data sharing initiative.
Ewart L, Aylott M, Deurinck M, Engwall M, Gallacher DJ, Geys H, Jarvis P, Ju H, Leishman D, Leong L, McMahon N, Mead A, Milliken P, Suter W, Teisman A, Van Ammel K, Vargas HM, Wallis R, Valentin JP. Ewart L, et al. Toxicol Sci. 2014 Dec;142(2):427-35. doi: 10.1093/toxsci/kfu198. Epub 2014 Sep 21. Toxicol Sci. 2014. PMID: 25246669
Assessing the predictive value of the rodent neurofunctional assessment for commonly reported adverse events in phase I clinical trials.
Mead AN, Amouzadeh HR, Chapman K, Ewart L, Giarola A, Jackson SJ, Jarvis P, Jordaan P, Redfern W, Traebert M, Valentin JP, Vargas HM. Mead AN, et al. Among authors: ewart l. Regul Toxicol Pharmacol. 2016 Oct;80:348-57. doi: 10.1016/j.yrtph.2016.05.002. Epub 2016 May 4. Regul Toxicol Pharmacol. 2016. PMID: 27155597 Free article.
74 results