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Reevaluating safety pharmacology respiratory studies within the ICH S7A core battery: A multi-company evaluation of preclinical utility and clinical translation.
Friedrichs GS, Abernathy MM, Ackley D, Clark M, DaSilva JK, Foley CM, Greiter-Wilke A, Henderson KA, Kremer JJ, Morimoto BH, Paglialunga S, Pugsley MK, Regan CP, Rossman EI, Segretti JA, Traebert M, Vargas HM, Wisialowski TA. Friedrichs GS, et al. Among authors: vargas hm. Regul Toxicol Pharmacol. 2024 Sep 16;153:105706. doi: 10.1016/j.yrtph.2024.105706. Online ahead of print. Regul Toxicol Pharmacol. 2024. PMID: 39293707
Improving the in vivo QTc assay: Nonclinical concentration-QTc modeling for risk assessment.
Wisialowski TA, Ether N, Foley CM, Kleiman R, Koshman Y, Leishman D, Martel E, Nichols JV, Popp J, Rajamani S, Riley S, Rossman EI, Vargas HM. Wisialowski TA, et al. Among authors: vargas hm. J Pharmacol Toxicol Methods. 2024 Jul-Aug;128:107515. doi: 10.1016/j.vascn.2024.107515. Epub 2024 May 20. J Pharmacol Toxicol Methods. 2024. PMID: 38777240 Free article. No abstract available.
Best practice considerations for nonclinical in vivo cardiovascular telemetry studies in non-rodent species: Delivering high quality QTc data to support ICH E14/S7B Q&As.
Rossman EI, Wisialowski TA, Vargas HM, Valentin JP, Rolf MG, Roche BM, Riley S, Pugsley MK, Nichols J, Li D, Leishman DJ, Kleiman RB, Greiter-Wilke A, Gintant GA, Engwall MJ, Delaunois A, Authier S. Rossman EI, et al. Among authors: vargas hm. J Pharmacol Toxicol Methods. 2023 Sep-Oct;123:107270. doi: 10.1016/j.vascn.2023.107270. Epub 2023 May 8. J Pharmacol Toxicol Methods. 2023. PMID: 37164235
Improving the in Vivo QTc assay: The value of implementing best practices to support an integrated nonclinical-clinical QTc risk assessment and TQT substitute.
Vargas HM, Rossman EI, Wisialowski TA, Nichols J, Pugsley MK, Roche B, Gintant GA, Greiter-Wilke A, Kleiman RB, Valentin JP, Leishman DJ. Vargas HM, et al. J Pharmacol Toxicol Methods. 2023 May-Jun;121:107265. doi: 10.1016/j.vascn.2023.107265. Epub 2023 Mar 28. J Pharmacol Toxicol Methods. 2023. PMID: 36997076 Free article. Review.
93 results