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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: yoshinaga t. 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.
Concentration-Response Modeling of ECG Data From Early-Phase Clinical Studies as an Alternative Clinical and Regulatory Approach to Assessing QT Risk - Experience From the Development Program of Lemborexant.
Murphy PJ, Yasuda S, Nakai K, Yoshinaga T, Hall N, Zhou M, Aluri J, Rege B, Moline M, Ferry J, Darpo B. Murphy PJ, et al. Among authors: yoshinaga t. J Clin Pharmacol. 2017 Jan;57(1):96-104. doi: 10.1002/jcph.785. Epub 2016 Aug 4. J Clin Pharmacol. 2017. PMID: 27338807 Clinical Trial.
General Principles for the Validation of Proarrhythmia Risk Prediction Models: An Extension of the CiPA In Silico Strategy.
Li Z, Mirams GR, Yoshinaga T, Ridder BJ, Han X, Chen JE, Stockbridge NL, Wisialowski TA, Damiano B, Severi S, Morissette P, Kowey PR, Holbrook M, Smith G, Rasmusson RL, Liu M, Song Z, Qu Z, Leishman DJ, Steidl-Nichols J, Rodriguez B, Bueno-Orovio A, Zhou X, Passini E, Edwards AG, Morotti S, Ni H, Grandi E, Clancy CE, Vandenberg J, Hill A, Nakamura M, Singer T, Polonchuk L, Greiter-Wilke A, Wang K, Nave S, Fullerton A, Sobie EA, Paci M, Musuamba Tshinanu F, Strauss DG. Li Z, et al. Among authors: yoshinaga t. Clin Pharmacol Ther. 2020 Jan;107(1):102-111. doi: 10.1002/cpt.1647. Epub 2019 Nov 10. Clin Pharmacol Ther. 2020. PMID: 31709525 Free PMC article.
A new paradigm for drug-induced torsadogenic risk assessment using human iPS cell-derived cardiomyocytes.
Ando H, Yoshinaga T, Yamamoto W, Asakura K, Uda T, Taniguchi T, Ojima A, Shinkyo R, Kikuchi K, Osada T, Hayashi S, Kasai C, Miyamoto N, Tashibu H, Yamazaki D, Sugiyama A, Kanda Y, Sawada K, Sekino Y. Ando H, et al. Among authors: yoshinaga t. J Pharmacol Toxicol Methods. 2017 Mar-Apr;84:111-127. doi: 10.1016/j.vascn.2016.12.003. Epub 2016 Dec 10. J Pharmacol Toxicol Methods. 2017. PMID: 27956204 Free article.
511 results