ABSTRACT
This chapter addresses some of the special considerations that are required when developing an in vitro–in vivo correlation (IVIVC) for a controlled release parenteral product. Although the Food and Drug Administration guidance on IVIVC emphasizes the usefulness of Level A and multiple Level C IVIVC, it addresses the development of a Level A IVIVC. The study design for modified release (MR) parenteral drug delivery systems should be similar to the design for oral formulations, if logistically possible. Although in vitro release (IVR) systems are well established for all types of oral formulations, standard IVR systems for MR parenterals do not exist. With oral or any other systemic drug delivery system the in vivo release is typically estimated using the measurement of drug within the systemic circulation. Investigators have attempted to develop a single IVIVC model for Type 2 plasma profiles using the two-stage deconvolution and the compartmental modeling approaches.
