Appraisal of ICH E14/S7B Q&As adopted in February 2022 using thorough QT/QTc study data for α4-integrin antagonist carotegrast methyl in Japanese healthy subjects

Appraisal of ICH E14/S7B Q&As adopted in February 2022 using thorough QT/QTc study data for α4-integrin antagonist carotegrast methyl in Japanese healthy subjects

We investigated how a lack of placebo control affects the interpretation of results of thorough QT/QTc (TQT) study. Results of TQT study in 48 healthy Japanese subjects assessing the effects of 480 and 960 mg of carotegrast methyl (test drug) and 400 mg of moxifloxacin (positive control) on the time...

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Bibliographic Details
Main Authors: Ryuichi Kambayashi, Ai Goto, Hiroko Izumi-Nakaseko, Ichiro Oikawa, Naoki Ikeda, Kazuki Matsuda, Yoshinori Takei, Akio Matsumoto, Yuji Kumagai, Atsushi Sugiyama
Format: Article
Language:English
Published: Elsevier 2022-11-01
Series:Journal of Pharmacological Sciences
Subjects:
ICH E14/S7B
Thorough QT/QTc
Carotegrast methyl
Moxifloxacin
J-Tpeak
Online Access:http://www.sciencedirect.com/science/article/pii/S1347861322000676

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http://www.sciencedirect.com/science/article/pii/S1347861322000676

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