Multi-laboratory comparisons of manual patch clamp hERG data generated using standardized protocols and following ICH S7B Q&A 2.1 best practices

Multi-laboratory comparisons of manual patch clamp hERG data generated using standardized protocols and following ICH S7B Q&A 2.1 best practices

Abstract Acute block of hERG channels is the most common mechanism underlying drug-induced QTC prolongation and potentially fatal Torsade de Pointes arrhythmia. Updates to ICH E14 Q&As now allow for using negative nonclinical data, including hERG, to support QTC risk assessment in late-stage cli...

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Main Authors: Claudia Alvarez Baron, Jun Zhao, Huimei Yu, Ming Ren, Nicolas Thiebaud, Donglin Guo, Giri Vegesna, Cheng-Hui Hsiao, Ryan DePalma, Sabyasachy Mistry, Isra Tariq, Md Shadiqur Rashid Roni, Omnia A. Ismaiel, Murali K. Matta, Vikram Patel, Manni Mashaee, Jose Vicente, Lars Johannesen, Jiansong Sheng, Simon Hebeisen, James Kramer, Andrew Bruening-Wright, Koji Nakano, Hiroshi Matsukawa, Jennifer Beck Pierson, Wendy W. Wu
Format: Article
Language:English
Published: Nature Portfolio 2025-08-01
Series:Scientific Reports
Subjects:
Cardiac safety
Delayed ventricular repolarization
Experimental uncertainty
Concentration-inhibition
Assay reproducibility
Safety margin
Online Access:https://doi.org/10.1038/s41598-025-15761-8
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