ABSTRACT
This chapter focuses primarily on the development, validation, and application of in vitro–in vivo correlation (IVIVC) models for oral dosage forms for both regulatory applications and for formulation development. The correlation between the in vitro dissolution performance of an oral dosage form, particularly those employing proprietary delivery technologies, to the corresponding in vivo performance has long been an important goal for the pharmaceutical scientist. However, interest in the field of in IVIVC has grown, reflecting the potential of this methodology as a tool for optimizing formulation development as well as a tool for supporting applications to regulatory authorities. The concept of IVIVC for extended release (ER) dosage forms that allows scientists to predict the expected bioavailability for an ER product based on its in vitro dissolution profile has long been discussed by the pharmaceutical community.
