Population PK modelling as an alternative route to bioequivalence

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