Human Abuse Liability Role in NDAs

Clinical Trials, Life Sciences, Pharmaceutical Regulation ,
  • April 15, 2014

Abuse and addiction are serious global health problems. All drugs with rewarding properties have the potential to be abused. Therefore the FDA requires most CNS acting drugs to be assessed for their abuse potential. The most common clinical method for drugs to be evaluated for their abuse potential is with a Human Abuse Liability (HAL) study.

The presentation will discuss when a HAL study will likely be required and how a HAL study is conducted.



Dr. Lynn Webster, Vice President of Scientific Affairs, PRA, and President, American Academy of Pain Medicine

Dr. Lynn Webster is co-founder and Chief Medical Director of Lifetree Clinical Research® (now CRI Lifetree Salt Lake City Center). His research interests are diverse. He is keenly interested in working with industry to develop safer and more effective therapies for chronic pain and addiction. He is a leading researcher in exploring the relationship of medications and sleep, with particular interest in analgesic-induced sleep-disordered breathing.

Dr. Webster is board certified in anesthesiology and pain medicine and is also certified in addiction medicine. He earned his doctorate of medicine from the University of Nebraska Medical Center and completed his residency in the University of Utah Medical Center’s department of anesthesiology.

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