JSM 2004 - Toronto

Abstract #301170

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Activity Number: 438
Type: Contributed
Date/Time: Thursday, August 12, 2004 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301170
Title: Cross-over Design and Model for Drug Abuse Potential Study
Author(s): Ling Chen*+ and Jun Shao
Companies: U.S. Food and Drug Administration and University of Wisconsin
Address: HFD 705, Rockville, MD, 20857,
Keywords: drug abuse ; mixed carryover effect ; self-evaluated response ; Williams design
Abstract:

In drug abuse potential clinical studies, there is large between-subject variability in the endpoint measurements based on self-evaluated responses. In addition, these studies are small, because of the difficulty in recruiting appropriate study subjects. The designs for such studies are thus typically cross-over, with self-control. The design for a study reviewed recently, comprised four replicates of a 6x6 Williams square crossover design with 24 subjects. Since the responses from the primary variables were very subjective and washout periods were not sufficient among the treatments, a serious mixed carryover effect occurred in the study. I will propose an improved model for similar drug abuse potential studies.

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