Sample size determination: Extended tables for the multiplicative model and bioequivalence ranges of 0.9 to 1.11 and 0.7 to 1.43.

作者: D Hauschke , V W Steinijans , E Diletti

DOI:

关键词: Normal distributionMultiplicative modelApplied mathematicsEquivalence (measure theory)MathematicsStatisticsSample size determinationLogarithmBioequivalence

摘要: For the two-period crossover design and a multiplicative model (logarithmic normal distribution) decision procedure of choice is based on inclusion shortest 90%-confidence interval for ratio expected medians test reference in equivalence range. This rule equivalent to two one-sided tests procedure. Sample sizes power latter have been given by Diletti et al. [1991] an range 0.8 1.25. Corresponding tables tighter 0.9 1.11 as well wider 0.7 1.43 are this amendment.

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