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Session Chair(s)
Lynn Roy Webster, MD
Vice President, Scientific Affairs
PRA Health Sciences, United States
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
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