Follow the rules and get to the finish line faster!

For more than a decade, applied electrophysiology has successfully been used to assess the cardiac toxicity of new drug. Although there still exists no way to ultimately predict severe cardiovascular adverse events like Torsades de Pointes, the world’s regulatory agencies now recognize the value of in-vitro safety pharmacology.

The increasing number of clinical observations pertaining to cardiovascular adverse effects led in 2000-2001 & 2005 to the approval by the European, Japanese and North American regulatory agencies of 2 major guidance documents issued by the ICH, i.e. S7A & S7B. Overtime, these have become regulatory landmarks for safety pharmacologists, introducing a uniform strategy for safety assessment in core battery systems.

This section of our website will guide you through some regulatory issues and considerations that now accompany any Investigational New Drug (IND) applications.