JSM 2005 - Toronto

Abstract #304400

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 398
Type: Contributed
Date/Time: Wednesday, August 10, 2005 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #304400
Title: Design and Analysis in Drug Abuse Potential Studies
Author(s): Ling Chen*+
Companies: U.S. Food and Drug Administration
Address: 12720 Twinbrook Parkway, Rockville, MD, 20850, United States
Keywords: Controlled substance ; Drug abuse ; Latin square ; Washout period
Abstract:

It is important to conduct a drug abuse potential study for a new drug that contains a controlled substance. The results from such a study frequently provide the basis for drug scheduling. Regarding statistical considerations, these trials often are designed with Latin Square with multiple treatments (test and positive control of different dose levels) and placebo. Appropriate length of washout period becomes crucial in design and analysis. In this talk, I will discuss advantages and disadvantages of commonly used designs and analyses in such studies.

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Revised March 2005