Defining the Liability in Abuse Liability: Practical Approaches to a Complex Analytical Problem
*Naama Levy-Cooperman, Altreos Research Partners Kerri Schoedel, Altreos Research Partners, Inc Keywords: abuse potential, randomized crossover, interpretation Human abuse potential studies are randomized crossover studies, with numerous measures, endpoints and comparisons. These studies use enriched populations and multiple doses of investigational drug, comparator(s) and placebo. These study design factors, along with the often non-linear dose-responses and non-normal distribution of subjective responses can create challenges in analysis and interpretation of study results. This presentation will introduce some of the key concepts in design of abuse potential studies, and discuss some of the inherent issues associated with analysis and interpretation of these data from a non-statistician's perspective, including potential underlying causes of these issues from a design perspective. The presentation will also offer some practical approaches to addressing some of these issues.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC