Power of Test in Bioequivalence Analysis. The Comparison of Tests in Beagle Dogs and Humans

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Abstract
The powers of ANOVA [analysis of variance] were calculated in the bioequivalence tests of diazepam tablets, flufenamic acid capsules, nalidixic acid tablets, griseofulvin tablets and cyclandelate capsules both in humans and beagle dogs. As measures of bioavailability, the peak serum (plasma) concentrations (the peak excretion rates) and the area under the serum concentration-time curves (the cumulative urinary excretion of drugs or metabolites) were more powerful than the peak time and the serum concentrations at each sampling time in the absorption phase in all drugs tested both in humans and beagle dogs. The estimated sizes of trials needed to detect 20% differences between the standard and test preparations tend to be larger in beagle dogs than in humans, especially in the trials of water-insoluble, neutral drugs such as griseofulvin and cyclandelate.