Human Abuse Potential: Study Design

Human Abuse Potential: Study Design

Human abuse potential (HAP) clinical studies are important components of the risk assessment for centrally-acting drugs, particularly those with psychoactive effects of interest, such as mood-elevating, stimulant, sedative, or hallucinogenic effects. Study Objectives...
Establishing Early Efficacy in Depression Clinical Trials

Establishing Early Efficacy in Depression Clinical Trials

This article is featured on The Association of Clinical Research Professionals (ACRP). Bradley D. Vince, DO and Sheldon H. Preskorn, MD discuss the process of developing a new molecular entity (NME) for FDA approval and strategies for establishing early efficacy. Key...