Published by BioAgilytix
ICH guidelines require that preclinical safety pharmacology studies to assess the risk of cardiotoxicity be conducted before beginning any clinical development program.
Investigation of cardiac toxicity in general toxicology studies is not covered by specific guidelines, with the following exception: the investigation of cardiac toxicity in the conduct of pre-clinical and clinical studies for the development of new drugs for the treatment of diabetes.
Cardiovascular complications are common among diabetic patients, and some recently introduced therapies have been shown to exacerbate these complications. The endpoints to be examined include the biomarkers of cardiac toxicity, troponin I and troponin T, and are clearly indicated in a Guidance document issued by the FDA in 2008…