Exposure-response analysis of drug-induced QT interval prolongation in telemetered monkeys for translational prediction to human.

Ryuichi Komatsu,Hiroshi Mizuno,Tomomichi Ishizaka,Akihito Ito,Tatsuya Jikuzono, Tadashi Kakoi,Masahiro Bando,Tadashi Koga, Jun Handa,Yukio Takahashi,Akihiro Kanno,Harushige Ozaki,Katsuyoshi Chiba

Journal of Pharmacological and Toxicological Methods（2019）

引用 19|浏览12

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摘要

Preclinical QT assessment in cynomolgus monkeys combined with ER analysis could identify the small QT effect induced by several QT drugs consistently with the outcomes in humans. Thus, the ER method should be regarded as useful for translational prediction of QT effects in humans.

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关键词

Cynomolgus monkey,Exposure-response analysis,J-ICET,Methods,Preclinical-clinical concordance,Probabilistic QT analysis,QT interval prolongation,QT rate-correction,Safety pharmacology,Telemetry

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