JSM Preliminary Online Program
This is the preliminary program for the 2008 Joint Statistical Meetings in Denver, Colorado.
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Some sessions have been moved to accommodate conflicts. Session numbers were resequenced April 4, 2008. This online program reflects these changes and always includes the most up-to-date information.


Activity Number: 279
Type: Contributed
Date/Time: Tuesday, August 5, 2008 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301513
Title: A Comparison of Methods To Determine Bioequivalence of Topical Dermatological Drug Products
Author(s): Ashlyn Hutchinson*+ and William Navidi and Annette Bunge and Berthe N'Dri-Stempfer
Companies: Colorado School of Mines and Colorado School of Mines and Colorado School of Mines and Colorado School of Mines
Address: Department of Mathematical and Computer Sciences, Golden, CO, 80401,
Keywords: Bioequivalence ; Topical Drugs ; Tape-stripping ; Efficiency
Abstract:

The process for establishing bioequivalence with topical dermatological drug products is regulated by the FDA. Different formulations of dermatological drugs are applied to various application sites on test subjects. The current protocol requires eight testing sites per drug formulation, and drug levels are measured at eight distinct times over a twenty-four hour period. This is problematic, as the increased number of test sites introduces more measurement error into the experiment and a large number of subjects are required to establish bioequivalence. A new technique, the Two Time, or TT, method requires only two application sites per subject. Simulation results indicate that the TT method is an effective method for determining bioequivalence in topical dermatological drugs. Benefits over the traditional method include the reduced time and cost due to fewer subjects and testing times.


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Revised September, 2008