Evaluating safety and toxicity

Abstract

Abstract Drug-induced toxicity poses a significant challenge for late-stage attrition of drugs. Potential drug candidate safety profile needs to be monitored closely to avoid adverse drug reactions. As of 2020, pharmaceutical companies and regulators in many countries rely on in vitro and in vivo testing. Although this approach provides researchers with necessary data, it has certain disadvantages. Certain types of toxicity remain undetected in the nonclinical phase due to physiological and metabolic variability between humans and other species and synergistic effects. Sitaxentan is an example of a drug that is not hepatotoxic in animal trials but causes significant liver injury in humans.