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Abstract Details

Activity Number: 167
Type: Topic Contributed
Date/Time: Monday, July 30, 2012 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #305890
Title: Responder Analysis in Human Abuse Potential Studies
Author(s): Ling Chen*+
Companies: FDA
Address: 10903 New Hampshire Avenue, Silver Spring, MD, 20903, United States
Keywords: Crossover Study ; Deterrent effects ; Human abuse potential study ; Williams Design

Besides analyzing the difference in means among treatments in human abuse potential studies, the Sponsors sometimes also included a responder analysis in their submission, especially for claiming deterrent effects of an extended release of a schedule II drug on its immediate release formulation. In this presentation, I will discuss the issues related to the current definitions of the percent of reduction for the test drug from the positive control drug by the sponsors. Then I will propose new definitions for the percent of reduction and a responder for Drug Liking on a bipolar visual analog scale (VAS). In addition, I will propose a new assessment criterion for the responder analysis in human abuse potential studies. The new methodologies can be easily extended to evaluate abuse potential measures other than Drug Liking VAS.

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