Kivonat:
Metrics are discussed which are used for the evaluation of
bioequivalence of modified-release formulations. In order to
ensure the therapeutic equivalence of the compared drug
products, it would be important to contrast measures which are
additional to area under the curve (AUC) and C (max). For
delayed-release products, the assessment of lag times is
informative. For extended-release dosage forms, comparisons of
the half-value duration and the midpoint duration time are
useful. For some modified-release formulations with complicated,
multiphasic concentration profiles, the comparison of partial
AUCs is important. In determinations of the bioequivalence of
extended-release dosage forms, investigations performed under
steady-state conditions rather than after single dosing can
yield enhanced probability of therapeutic equivalence,
especially with substantial accumulation of the drug products.
In steady-state investigations of bioequivalence, evaluation of
the trough concentration and of the peak trough fluctuation is
informative.