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Activity Number:
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145
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Type:
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Contributed
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Date/Time:
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Monday, July 30, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308326 |
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Title:
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An Equivalence Test Based on the Duration of Treatment Effect as Measured by Median Time-to-Event
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Author(s):
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Suriani Pokta*+ and Jihao Zhou
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Companies:
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Allergan, Inc. and Allergan, Inc.
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Address:
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2525 Dupont Drive, Irvine, CA, 92612,
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Keywords:
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equivalence test ; median time-to-event ; duration of treatment effect
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Abstract:
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In clinical trials involving systemic compounds, bioequivalence (BE) studies are usually adequate to demonstrate the therapeutic equivalence between a new formulation and a standard formulation, or between a generic drug and a reference-listed drug. However, BE studies are irrelevant for topical compounds. Therefore, clinical equivalence trials are required. In this paper we present a new equivalence test based on the duration of treatment effect as measured by median time-to-event. First, we derive a parametric equivalence test based on an exponential survival distribution with censoring. Then we develop a nonparametric equivalence test based on median Kaplan-Meier estimates of the duration of treatment effect. The performance of these tests is assessed through simulated data. For illustration, we apply the above methods to a published clinical trial.
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