戻る Agenda
Human Abuse Liability Testing in CNS Drug Development
Session Chair(s)
Lynn Roy Webster, MD
Vice President, Scientific Affairs
PRA Health Sciences, United States
This workshop will address clinical aspects of conducting human abuse liability studies. It will provide insight on FDA’s Draft Decision Tree on Assessment of Abuse Potential and the appropriate methodology for assessment of abuse liability potential.
**Due to workshop format, seating will be limited and will be available on a first come, first served basis.
The Boston Convention and Exhibition Center (BCEC) has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.
Learning Objective : Discuss the FDA Guidance for Industry Assessment of Abuse Potential of Drugs; Explain how the design of the human abuse liability study may affect labeling; Recognize when human abuse liability studies are indicated.
Speaker(s)
What You Must Know Before Conducting a Human Abuse Liability Study
Lynn Roy Webster, MD
PRA Health Sciences, United States
Vice President, Scientific Affairs
Cause for Discrimination: Importance of the Discrimination Phase in Human Abuse Liability Studies
Jack Henningfield, PHD
Pinney Associates, United States
Vice President, Research, Health Policy, and Abuse Liabiliy
Decisions, Decisions: How the FDA Decides Whether or Not to Require a HAL Study
Robert A Medve, MD
Nektar Therapeutics, United States
Chief Medical Officer