Statistical issues in bioequivalence

Stephen Senn*

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

34 Citations (Scopus)


There has been much work recently on individual bioequivalence and the topic has attracted considerable controversy. Some previous controversies regarding average bioequivalence are examined. It is argued that a contributory factor in these controversies may have been confusion over the purpose of bioequivalence trials. It is concluded that this purpose needs further clarification before guidelines for individual bioequivalence can be established and indeed that such guidelines may turn out to be unnecessary.

Original languageEnglish
Pages (from-to)2785-2799
Number of pages15
JournalStatistics in Medicine
Issue number17-18
Publication statusPublished - 15 Sept 2001
Externally publishedYes


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