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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: kleiman rb. 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. Among authors: kleiman rb. 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.
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