Drug-induced long QT syndrome: Concept and nonclinical models for predicting the onset of drug-induced torsade de pointes in patients in compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E14/S7B guidance.

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Tác giả: Ai Goto, Hiroko Izumi-Nakaseko, Ryuichi Kambayashi, Atsushi Sugiyama, Akira Takahara, Yoshinori Takei

Ngôn ngữ: eng

Ký hiệu phân loại: 363.3497 Other aspects of public safety

Thông tin xuất bản: United States : The Journal of pharmacology and experimental therapeutics , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 739761

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) established S7B and E14 guidelines in 2005 to prevent drug-induced torsade de pointes (TdP), effectively preventing the development of high-risk drugs. However, those guidelines hampered the development of some potentially valuable drug candidates despite not being proven to be proarrhythmic. In response, comprehensive in vitro proarrhythmia assay and exposure-response modeling were proposed in 2013 to reinforce proarrhythmic risk assessment. In 2022, the ICH released E14/S7B questions and answers (stage 1), emphasizing a "double negative" nonclinical scenario for low-risk compounds. For "non-double negative" compounds, new questions and answers are expected to be enacted as stage 2 shortly, in which more detailed recommendations for proarrhythmia models and proarrhythmic surrogate markers will be provided. This review details the onset mechanisms of drug-induced TdP, including I
1. Drug
2. Induced
3. Long
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