Assessment of the possibility of using comparative <Emphasis Type="Italic">in vitro</Emphasis> dissolution kinetics (biowaiver) instead of <Emphasis Type="Italic">in vivo</Emphasis> bioequivalence evaluation for establishing the interchanbeability of generic drugs

One way of establishing the interchangeability of generic drugs is based on an in vitro study of the dissolution kinetics (biowaiver). The most common approaches for assessing the ability to use the biowaiver procedure instead of the traditional bioequivalence evaluation for generics are reviewed.