Some Statistical Considerations on 2×k Crossover Designs for Bioequivalence Trial
نویسندگان
چکیده
منابع مشابه
On statistical power for average bioequivalence testing under replicated crossover designs.
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...
متن کاملon some bayesian statistical models in actuarial science with emphasis on claim count
چکیده ندارد.
15 صفحه اولAdditional results for 'Sequential design approaches for bioequivalence studies with crossover designs'.
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 ...
متن کاملDetermination of sample size for two stage sequential designs in bioequivalence studies under 2x2 crossover design
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...
متن کاملMultiple testing for bioequivalence with pharmacokinetic data in 2 x 2 crossover designs.
To evaluate globally the average bioequivalence of a test drug to a reference drug in a pharmacokinetic (PK) study under a 2 x 2 crossover design, we consider directly comparing the associated drug concentration-time curves. Statistical models for the drug concentrations are suggested when the concentrations measured at different time points are distributed according to a generalized gamma dist...
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ژورنال
عنوان ژورنال: Korean Journal of Applied Statistics
سال: 2013
ISSN: 1225-066X
DOI: 10.5351/kjas.2013.26.4.675