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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. Among authors: bialecki r. 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
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: bialecki r. 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
Assessment of cisplatin-induced kidney injury using an integrated rodent platform.
Chen Y, Brott D, Luo W, Gangl E, Kamendi H, Barthlow H, Lengel D, Fikes J, Kinter L, Valentin JP, Bialecki R. Chen Y, et al. Among authors: bialecki r. Toxicol Appl Pharmacol. 2013 May 1;268(3):352-61. doi: 10.1016/j.taap.2013.01.032. Epub 2013 Feb 13. Toxicol Appl Pharmacol. 2013. PMID: 23415679
Approaches to seizure risk assessment in preclinical drug discovery.
Easter A, Bell ME, Damewood JR Jr, Redfern WS, Valentin JP, Winter MJ, Fonck C, Bialecki RA. Easter A, et al. Among authors: bialecki ra. Drug Discov Today. 2009 Sep;14(17-18):876-84. doi: 10.1016/j.drudis.2009.06.003. Epub 2009 Jun 21. Drug Discov Today. 2009. PMID: 19545644 Review.
40 results