Controversies in bioequivalance

What is it about?

Different approaches to bioequivalence are described and their advantages and disadvantages discussed

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Why is it important?

Individual bioequivalence is discussed. 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.