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Exploring the Evolving Requirements for the Clinical Assessment of Abuse and Dependence Potential of CNS-Active Drugs
Session Chair(s)
Beatrice Setnik, PhD
Dept of University of Toronto; VP, Scientific and Clinical Strategy, Early Phase
Syneos Health, United States
Drug scheduling is implemented by regulatory agencies to mitigate the risk of drug abuse. Learn about the pivotal clinical studies required to evaluate the abuse and dependence potential of CNS-active drugs and the evolving regulatory requirements.
Learning Objective : Describe the most recent FDA recommendations for the clinical evaluation of abuse and physical dependence of CNS-active drugs; Discuss how this data is used to determine drug scheduling and the implications of controlled substances;Evaluate the best strategies to design robust abuse/dependence potential clinical trials.
Speaker(s)
Panelist
Jack Henningfield, PhD
Pinney Associates, United States
Vice President, Research, Health Policy, and Abuse Liabiliy
Panelist
Beatrice Setnik, PhD
Syneos Health, United States
Dept of University of Toronto; VP, Scientific and Clinical Strategy, Early Phase
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