JSM 2005 - Toronto

Abstract #302836

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 522
Type: Contributed
Date/Time: Thursday, August 11, 2005 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #302836
Title: A New Method to Identify the Minimum Effective Dose
Author(s): Jianan Peng*+ and Chun-In C. Lee and Lin Liu
Companies: Acadia University and Memorial University of Newfoundland and University of California, San Diego
Address: 12 University Avenue, Wolfville, NS, B4P 2R6, Canada
Keywords: Minimum effective dose ; DR method ; Order restricted inference
Abstract:

The assessment of dose-response is a critical part of a drug development program in biopharmaceutical studies. When analyzing dose-response studies, one of the most important questions is whether there is a dose-response effect and, if so, what is the minimum effective dose? Usually the dose-response curves are assumed to be monotonic. However, in some situations, there may be a negative response at low doses. Then, it is appropriate to make a partial monotone dose-response assumption. We propose a new, one-sided, multiple contrast test that takes into account the ordering of the doses under the partial monotonic assumption. Based on the partitioning principle, we combine the new one-sided test and two-sample t test to develop a stepwise confidence interval procedure to identify the MED. The new stepwise confidence interval procedure is more powerful than Hsu and Berger's DR method, which does not make use of the ordering information of the doses.


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Revised March 2005