Impact of Differences in Regional Bioavailability on IVIVC Development for Modified Release Drug Products

The assessment of an IVIVC for a Modified Release (MR) dosage form is a key goal for a development team. If established, the benefits include the use of biowaivers in lieu of bioequivalence (BE) studies for managing change, improved justification of drug product
specification and an enhanced quality by design (QbD) understanding of the product and process. 

Here we describe the optimization of an IVIVC for a small molecule (Cmp-1) using a combined understanding of human regional bioavailability, intravenous pharmacokinetics (IVPK), oral PK and pharmaceutical data for several MR prototypes