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Abstract Details
Activity Number:
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167
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 30, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #305890 |
Title:
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Responder Analysis in Human Abuse Potential Studies
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Author(s):
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Ling Chen*+
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Companies:
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FDA
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Address:
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10903 New Hampshire Avenue, Silver Spring, MD, 20903, United States
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Keywords:
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Crossover Study ;
Deterrent effects ;
Human abuse potential study ;
Williams Design
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Abstract:
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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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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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