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Activity Number: 45
Type: Contributed
Date/Time: Sunday, August 9, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #316770
Title: Missing Data Issue for Sedative Products in Human Abuse Potential Studies
Author(s): Ling Chen*
Companies: FDA
Keywords: Abuse Potential ; Human abuse potential study ; Missing data ; Sedative products
Abstract:

The human abuse potential study plays an important role in understanding whether or not a drug produces positive subjective responses indicative of abuse potential. Such a study is a randomized, double-blind, placebo- and positive- controlled crossover study on recreational drug users. When assessing human abuse potential for a sedative product, we often observe missing data around Tmax from large number of subjects. The missing data were due to AEs (somnolence, drowsiness and confusion) related to the sedative effect of the treatment. In the presentation, I will discuss the issue, and possible solutions.


Authors who are presenting talks have a * after their name.

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