What is it about?
Proposed FDA requirements for individual bioequivalance do not make sense because the authors of the proposals have lost sight of the purpose of bioequivalance studies.
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Why is it important?
The purpose of bioequivalence studies is not to show that every person would have an identical effect when given the new formulation as when given the old but that the new formulation would be expoected to fulfill the same regulatory requirements as the old if put through the same drug development programme. Given this purpose the goal of individual bioequivalance is unnecessary.
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This page is a summary of: In the blood: proposed new requirements for registering generic drugs, The Lancet, July 1998, Elsevier,
DOI: 10.1016/s0140-6736(98)85007-1.
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