On the assessment of variability in bioavailability/bioequivalence studies |
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Authors: | Jen-Pei Liu Shein-Chung Chow |
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Affiliation: | 1. Berlex Laboratories , Wayne, NJ, 07470;2. Bristol-Myers Squibb , Plainsboro, NJ, 08536 |
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Abstract: | A procedure is proposed for the assessment of bioequivalence of variabilities between two formulations in bioavailability/bioequivalence studies. This procedure is essentially a two one-sided Pitman-Morgan’s tests procedure which is based on the correlation between crossover differences and subject totals. The nonparametric version of the proposed test is also discussed. A dataset of AUC from a 2×2 crossover bioequivalence trial is presented to illustrate the proposed procedures. |
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Keywords: | crossover bioequivalence variability of bioavailability Pitman-Morgan's F test |
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