GLP in safety pharmacology studies: report card after 15 years

Abstract

The pivotal role of safety pharmacology in the safety testing of new drugs is now well established, having received a large impetus through the regulatory requirement of this type of study and the appearance of the ICHS7A guidance in 2001 (US FDA, 2001). This has contributed substantially to development of safer medicines and the avoidance of untoward effects in early clinical trials. Many may not be aware that during the negotiations leading to the ICH guidance, a major discussion point was whether safety pharmacology studies should be conducted according to good laboratory practice (GLP) and there were many valid reasons for and against this requirement (Bass, Hombo, Kasai, Kinter, & Valentin, 2015). However, regulatory safety studies are viewed to necessitate GLP and this won the day. Although few would now question the need for GLP compliance for a safety pharmacology “core battery” study, we should still take the time to evaluate how this has impacted safety testing and its quality