How to Perform IVIVC for Extremely Long Acting Drugs

In vitro-in vivo correlation (IVIVC) is a predictive mathematical tool that describes the relationship between an in vitro property of a drug dosage form and an in vivo pharmacokinetic response. Drug developers frequently use this approach to waive the requirement to show evidence of in vivo bioavailability or bioequivalence if the equivalent in vivo performance can be predicted from appropriate in vitro data. A meaningful IVIVC can help guide formulation and/or process development changes in the various stages of drug product development. In addition, an IVIVC can support and/or validate the use of an in vitro dissolution method and can help set clinically relevant dissolution specifications to ensure product quality.

In theory, developing an IVIVC is a straightforward approach. Some complex, non-oral drug formulations such as implants or transdermal patches are designed to act for days, months, and even years. IVIVC then becomes a real challenge as the in vitro dissolution must reflect the same release mechanism as in vivo formulation. And an important phenomenon: time scaling— a difference between the in vitro and in vivo dissolution rates— is often observed. This webinar investigated the use of in vitro and in vivo models to find direct time scaling factors and confirm the similarity of the in vitro and in vivo release mechanisms.