When to Assess a Drug’s Potential for Abuse: Series Introduction

Drug abuse and potential drug abuse are critical issues for today’s pharmaceutical White Pills Drug Abuse industry and the health of patients. Understanding the latest FDA regulatory requirements, different study types, relevant timelines and logistics can be challenging. Conducted at a critical stage of drug development, the assessment for drug abuse potential is complex and must be acceptable to regulators.

If a drug or its major metabolite penetrates the brain, then an abuse potential assessment is required, regardless of the therapeutic indication. 

Developing a strategy around relevant timelines

The doses for drug abuse testing are selected based on the exposure/plasma levels produced in humans by the highest therapeutic dose. Therefore, drug abuse studies are not recommended until the human therapeutic dose range has been determined; however, your testing strategy should begin much earlier. Continue reading

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