Herg Safety Testing
Herg Safety Testing |
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Due to repeated documentation of drug-induced heart failures
in the eighties there was increasing concern in the regulatory settings.
Today governmental agencies and the International Conference
on Harmonisation
(ICH) recommend to assess the potential of a drug to prolong the QT
interval as measured in the electrocardiogram (ECG). Attempts to solve
the problem included:
Removal of drugs from the market by the FDA (e.g. terfenadine, cisapride)
Cardiac Arrhythmia Suppression Trial (CAST, 1991)
Points to consider Document by the Comitee for Proprietary Medicinal Products (CPMP/986/96)
Guidelines by the International Conference on Harmonisation (ICH S7A and S7B, 2000, 2002)
The rapid delayed rectifier current (I Kr) is important for cardiac action potential repolarization. Suppression of I Kr function by adverse drug effects (e.g. terfenadine, cisapride, astemizole) can induce a prolongation of the QT interval carrying elevated risk of life-threatening arrhythmias. It is believed that I Kr is mediated by the potassium channel HERG. According to the ICH S7A and S7B guidelines the analysis of compounds for inhibition of Herg currents allows the assessment of the potential for QT prolongation.
B'SYS HERG services
HERG Early Screening (from single compound up to HTS)
GLP HERG for IC50 Determination in compliance with GLP principles