Addressing the Challenges of Abuse Liability Testing – Meeting Regulatory Requirements and Study Design

Addressing the Challenges of Abuse Liability Testing – Meeting Regulatory Requirements and Study Design

Identifying clinically useful compounds and developing a novel drug treatment to improve human health has many rewards. But with increasing press about the growing abuse of prescription medications and potentials for physiological or physical dependence, regulatory agencies around the world have taken note.

Called abuse liability testing, this stage of drug development was first officially recognized in 1970 with the U.S. Controlled Substances Act. Since then, many iterations and guidelines have been developed to determine a compound’s potential for abuse.

Abuse liability studies are very important because they are required by the regulatory agencies in U.S., Europe, and even Asia for setting the scheduling of new chemical entities that come into the marketplace. Continue reading