Chapter 9 - Clinical Evaluation of Abuse Potential for New Pharmaceuticals: The Assessment of Abuse Potential during Drug Development

Abstract

This chapter reviews the conduct of the human abuse potential study from the regulatory perspective, as outlined in the Food and Drug Administration (FDA)'s 2010 Guidance for Industry: Assessment of Abuse Potential of Drugs. Using the guidance as an outline, the chapter describes how human abuse potential studies are conceived and conducted, how they are analyzed, how Adverse Events (AEs) are considered, and how abuse liability may continue to be monitored after drug approval. Human abuse potential trials by themselves are not sufficient to bring about drug scheduling; however, they are a critical piece of the abuse liability assessment submitted to the FDA as part of a New Drug Application (NDA). Thus, this chapter summarizes a critical piece of the regulatory package.