[Assessment of bioequivalence].
Bioequivalence tests in Japan are now under the improvement according to the WHO guidance. This article describes the desirable assessment of bioequivalence where the use of discriminatory subjects, application of confidence interval methods, logarithmic transformation of pharmacokinetic data are recommended. The role of dissolution tests in bioequivalence assessment is also discussed.
Aoyagi
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D001682:Biological Availability; D003627:Data Interpretation, Statistical; D017408:Guidelines as Topic; D006801:Humans; D010599:Pharmacokinetics; D012995:Solubility; D013810:Therapeutic Equivalency; D014944:World Health Organization