Regulatory Guidelines and Methodological Approaches to Assess Prescription Drug Abuse/Misuse During CNS Drug Development

Chairs:  Beatrice Setnik, Marta Sokolowska, Michael Klein

Prescription drug abuse continues to be a major public health concern that has led to the requirement of assessing the abuse potential of CNS dugs in development.  This session will review the FDA regulatory requirements to assess abuse potential of CNS drugs and will discuss the methodological approaches involved in collecting data across clinical development, including human abuse potential studies.  Methodology and selection of appropriate endpoints to assess abuse, misuse, and dependence across patient and post-marketing studies will also be discussed.
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