Assessing Average Bioequivalence for 2×2 Crossover Design with Covariates
نویسندگان
چکیده
منابع مشابه
A More Powerful Average Bioequivalence Analysis for the 2x2 Crossover
The 2 × 2 crossover is commonly used to establish average bioequivalence of two treatments. In practice, the sample size for this design is calculated under an implicit belief that the true average bioavailabilities of the two treatments are (almost) identical. However, the ”standard” average bioequivalence analysis does not reflect this prior belief and this leads to a loss in efficiency. The ...
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In its recent guidance on bioequivalence, the U.S. Food and Drug Administration (FDA) recommends a two-sequence, four-period (2 x 4) replicated crossover design be used for assessment of population and individual bioequivalence [FDA. Guidance for Industry on Statistical Approaches to Establishing Bioequivalence; Center for Drug Evaluation and Research, Food and Drug Administration: Rockville, M...
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In 2008, this group published a paper on approaches for two-stage crossover bioequivalence (BE) studies that allowed for the reestimation of the second-stage sample size based on the variance estimated from the first-stage results. The sequential methods considered used an assumed GMR of 0.95 as part of the method for determining power and sample size. This note adds results for an assumed GMR ...
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For locally acting drug products such as nasal aerosols and nasal sprays, therapeutic equivalence between two drug products may be established by in vitro bioequivalence studies based on measurements intended to reflect the rate and extent to which the active ingredient becomes available at the site of action. For cascade impaction or multistage liquid impinger for particle size distribution, p...
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Sequential design is an adaptive design that allows for pre-mature termination of a trial due to efficacy or futility based on the interim analyses. The concept of sequential statistical methods was originally motivated by the need to obtain clinical benefits under certain economic constraints. That is for a trial for a positive results, early stopping ensures that a new drug product can exploi...
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ژورنال
عنوان ژورنال: Korean Journal of Applied Statistics
سال: 2011
ISSN: 1225-066X
DOI: 10.5351/kjas.2011.24.1.161