生物学的同等性試験における検出力.主としてヒト試験とビーグル犬試験の比較

概要

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The powers of ANOVA 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.
社団法人日本薬学会の論文
1984-02-25