Statistical issues in bioequivalance

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 (C) 2001 John Wiley & Sons, Ltd.