Understanding The In-Vitro/In-Vivo Relationship (IVIVR): Inhaled Medicinal Products

By Neha Patel and Andy Cooper, Kindeva Drug Delivery

In-vitro/in-vivo relationship (IVIVR) modeling can help researchers and product developers understand and predict clinical outcomes. Applied intuitively, IVIVR modeling allows a correlation between clinically relevant in-vitro test data and in-vivo test data with the aim of providing a more accurate prediction of the actual lung dose. These data can ultimately provide confidence in expected pharmacokinetic (PK) study outcomes for the comparison of two products, or improve dose-finding study designs during early phase clinical studies, as well as potentially reduce development cost and timelines.

Standard in-vitro methodology can demonstrate product stability and provides directional information towards how much drug is delivered to the lung or deposited in the throat, however predictions of product performance in-vivo are improved with more clinically relevant data. The emergence of new IVIVR tools and methodologies in recent years, combined with access to clinically relevant in-vitro data and significant historical and ongoing in-vivo knowledge, allows us to bridge this knowledge gap in a more meaningful way, de-risking the clinical program.

Explore IVIVR in practice to understand the value of IVIVR modeling, and review Kindeva’s expertise and capability to perform IVIVR modeling in-house.