On the test of liu and chow's procedure for assessing equivalence in variability of bioavailability |
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Authors: | Keh-Wei Chen Alex S Papadopoulos Shein Chung Chow |
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Institution: | 1. Department of Mathematics , University of North Carolina at Charlotte , Charlotte, NC, 28223;2. Biostatistics and Data Management , Company Plainsboro , NJ, 08536Bristol-Myers Squibb |
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Abstract: | Similar to Schuirmann's two one-sided tests procedure for assessment of bioequivalence in average bioavailability (Schuirmann,), Liu and Chow proposed a two one-sided tests procedure for assessment of equivalence of variability of bioavailability. Their procedure is derived based on the correlation between crossover differences and subject totals. In this paper, we examined the performance of their test procedure in terms of its test size and power for various situations where the intersubject variability and the intrasubject variability of the test drug product are relatively larger, similar, and smaller than that of the intrasubject variability of the reference drug product. |
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Keywords: | bioequivalence average bioavailability variability of bioavailability population equivalence Pitman-Morgan's F test |
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