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1992•Communication in Statistics- Theory and MethodsRequires access

On the assessment of variability in bioavailability/bioequivalence studies

Jen‐pei Liu, Shein‐Chung Chow

Open publisher page 41 citations

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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What this paper is about

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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OpenAlex reports 41 citations for this work. Citation counts describe recorded attention and do not establish research quality.

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Available 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.

Key concepts: Bioequivalence, Bioavailability, Nonparametric statistics, Crossover study, Crossover, Statistics, Mathematics, Econometrics

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