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Time for a Fully Integrated Nonclinical-Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective.
Vargas HM, Rolf MG, Wisialowski TA, Achanzar W, Bahinski A, Bass A, Benson CT, Chaudhary KW, Couvreur N, Dota C, Engwall MJ, Michael Foley C, Gallacher D, Greiter-Wilke A, Guillon JM, Guth B, Himmel HM, Hegele-Hartung C, Ito M, Jenkinson S, Chiba K, Lagrutta A, Levesque P, Martel E, Okai Y, Peri R, Pointon A, Qu Y, Teisman A, Traebert M, Yoshinaga T, Gintant GA, Leishman DJ, Valentin JP. Vargas HM, et al. Among authors: engwall mj. Clin Pharmacol Ther. 2021 Feb;109(2):310-318. doi: 10.1002/cpt.2029. Epub 2020 Sep 24. Clin Pharmacol Ther. 2021. PMID: 32866317 Free PMC article. Review.
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
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: engwall mj. 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
Safety Pharmacology Evaluation of Biopharmaceuticals.
Amouzadeh HR, Engwall MJ, Vargas HM. Amouzadeh HR, et al. Among authors: engwall mj. Handb Exp Pharmacol. 2015;229:385-404. doi: 10.1007/978-3-662-46943-9_15. Handb Exp Pharmacol. 2015. PMID: 26091648 Review.
38 results