Population PK modelling as an alternative route to bioequivalence

Abstract

Demonstrating bioequivalence (BE) is important for the development of lower-cost generic products, and also for approving post-submission manufacturing changes. However, for many complex parenteral products, BE demonstration can be very challenging. For example, long-acting injectable products are engineered to have an extended release over several weeks or months, but this also means that traditional BE study can take many months or years to perform. Here, we summarise how population PK modeling, which captures differences in PK profiles due to population variation, could be used to explore hundreds of virtual formulations, and thus determine a range of products that are bioequivalent after both multiple and single dosing. This provides a guide for formulation development but also opens alternative, more streamlined routes to BE assessment.

Keywords

• bioequivalence
• population pk modelling
• complex parenterals
• long acting injectables