{"title":"[Assessment of bioequivalence].","authors":"N Aoyagi","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":11656,"journal":{"name":"Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"1996-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
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.
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