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 QT_C 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 QT_C risk assessment in late-stage clinical development. To interpret the hERG results, understanding hERG assay reproducibility or hERG data variability is pivotal. Protocol and best practice recommendations have been provided with the goal of minimizing lab-to-lab data differences, but the impact remains unclear. To fill this knowledge gap, hERG data from a HESI-coordinated multi-laboratory study were leveraged. Using standardized protocol and following best practices for patch clamp studies, five laboratories tested 28 d

SUBMITTER: Alvarez Baron C 

PROVIDER: S-EPMC12357877 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature