Drug Safety in preclinical studies
The development of new medicines is a long and expensive process. Despite growing efforts in R&D over the last decades, the attrition rate due to safety (especially cardiac toxicity) remains a major challenge for the pharmaceutical industry. Hence, safety assessment is of crucial importance during preclinical drug evaluation, and is particularly vital for upholding the integrity of the study and regulatory compliance.
“Safety pharmacology studies are defined as those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions, in relation to exposure in the therapeutic range and above” (source ICH S7A).