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The fact that two generics which are each bioequivalent to a reference
product but are not bioequivalent to each other presents a potential public
safety concern. In fact, this points out a particular weakness of the
average bioequivalence approach; the problem may be addressed by invoking a
population BE or a individual BE requirement for a generic formulation to be
approved. The former would ensure that the variability of new formulation
is not greater than for the reference, while the latter provides, in
addition, explicit information on the subject-by-formulation interaction.
James Hui, Ph.D.
Clinical Pharmacology and Drug Metabolism
Triangle Pharmaceuticals, Inc.
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