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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 - #309045 |
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Title:
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A Multivariate Test for Population Bioequivalence
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Author(s):
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Inna Chervoneva*+ and Terry Hyslop and Walter W. Hauck
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Companies:
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Thomas Jefferson University and Thomas Jefferson University and Kimmel Cancer Center at Jefferson
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Address:
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1015 Chestnut St Suite M100, Philadelphia, PA, 19107,
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Keywords:
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Multivariate equivalence ; Population bioequivalence ; In vitro bioequivalence ; Modified large-sample confidence intervals
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Abstract:
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We propose a multivariate generalization of the univariate criteria for testing population bioequivalence. Most approaches for testing multivariate equivalence consider a multivariate equivalence region, which implies simultaneous comparison of means in each dimension. In contrast, our proposal combines a comparison of means and a comparison of variances into a single aggregate criterion, using the trace of the covariance matrix as a scalar measure of the total variability. We use a confidence interval approach to testing and construct two versions of the modified large-sample confidence interval for the linearized multivariate criterion. In a simulation study, we evaluate the empirical coverage of these confidence intervals and rejection rates of the corresponding tests. The proposed methodology is illustrated with an example of testing equivalence of the spray pattern of nasal sprays.
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