Reducing Drug Attrition: Safety Pharmacology

Abstract

Safety pharmacology studies have been used to support drug discovery and development programs by many sponsors for decades. The objectives of these studies are to identify and characterize pharmacology activities of drug candidates that can contribute to adverse effects and safety of clinical trial participants and patients. International guidelines for safety pharmacology were adopted in 2001 and 2005, and results from these studies are now a component of almost all regulatory submissions. By insuring the quality of the data from these studies and effectively communication results in terms of a risk assessment, the safety pharmacology package can be used to identify drug candidates with lower risk for attrition and to mitigate or better manage safety risks during clinical development.