ABSTRACT
The usefulness of an in vitro/in vivo correlation (IVIVC) during product development depends on how accurately it can predict resultant plasma concentrations from any given set of in vitro data. This, in turn, is heavily dependent on the design of the in vitro and in vivo studies used to develop and validate the IVIVC. The design of in vitro studies is covered in another chapter, but the temporal aspect of the in vitro study as it relates to the IVIVC will be covered here. The major emphasis of this chapter, however, will be the design of the in vivo study.
