Research Article
Statistical issues in bioequivalance
Stephen Senn,
Corresponding Author
Stephen Senn
Department of Epidemiology and Public Health, Department of Statistical Science, University College London, Gower Street, London, U.K.
Department of Epidemiology and Public Health, Department of Statistical Science, University College London, Gower Street, London WC1E 6BT, U.K.Search for more papers by this authorStephen Senn,
Corresponding Author
Stephen Senn
Department of Epidemiology and Public Health, Department of Statistical Science, University College London, Gower Street, London, U.K.
Department of Epidemiology and Public Health, Department of Statistical Science, University College London, Gower Street, London WC1E 6BT, U.K.Search for more papers by this authorAbstract
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. Copyright © 2001 John Wiley & Sons, Ltd.
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Citing Literature
Special Issue:Statistical Issues in Biopharmaceutical Environments: Towards the Next Millennium
15 ‐ 30 September 2001
Pages 2785-2799
