Herg Safety Testing

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.

bSys HERG services

• HERG Early Screening (from single compound up to HTS)

• GLP HERG for IC₅₀ Determination in compliance with GLP principles