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Abstract Details

Activity Number: 306
Type: Contributed
Date/Time: Tuesday, July 31, 2012 : 8:30 AM to 10:20 AM
Sponsor: Section on Bayesian Statistical Science
Abstract - #305198
Title: Considerations on the Bayesian Dosing Window Escalation
Author(s): Xue Lin*+ and Boguang Zhen
Companies: FDA and FDA/CBER
Address: 1401 Rockville Pike, Rockville, MD, 20852, United States
Keywords: Bayesian ; dose escalation

Various methods have been proposed for dose escalation to find the MTD (maximum tolerated dose). Examples include the CRM (continuous reassessment method), MCRM (modified CRM), and BLRM (Bayesian logistic regression model). In those cases, the study drug is often chemical compound thus the dosage can be strictly controlled and the dose escalation is from one single dose to anther. An interesting extension of single dosage escalation is dosing window escalation in which the escalation is from one dosing window to another. We study several aspects of the dosage window escalation problem, including the impact of the window size, the issues with the generalization of the forth mentioned methods. Results from a simulation study will be presented.

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