ICH, Mandatory Harmonized guidelines for cardiac safety studies

All drug in preclinical developments for human use are subjected to mandatory ICH guidelines (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use). Current standards require preclinical safety studies to analyze the effect of your compound on all vital functions, i.e. cardiovascular, renal, pulmonary, gastrointestinal and neurological.

Logo ICH

Cardiovascular safety studies have to be conducted in compliance with:


The Guideline on safety pharmacology studies for human pharmaceuticals. Safety Pharmacology, as defined in guideline ICH S7A aims to assess potential adverse effects of a test substance on vital functions: cardiovascular, respiratory and central nervous system are considered as the vital organ systems that should be studied in the core battery.


As an extension of the ICH S7A guideline, The S7B guideline focuses on the assessment of the effects of pharmaceuticals on ventricular repolarization and proarrhythmic risk. S7B details the guidelines on Safety Pharmacology studies to assess the potential for delayed ventricular repolarisation (QT interval prolongation) in human pharmaceuticals.

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