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