Assessing the Impact of Genetic Polymorphisms and drug-drug interactions on exposure – Is a clinical study necessary?

A recent paper – authored by scientists working at the US Food and Drug Administration (FDA) – describes the development and validation of PBPK models to assess the impact of pharmacogenetics and poly-pharmacy on drug disposition

PBPK modeling and simulation is gaining increasing acceptance due to the enormous cost and time saving benefits that can be realized through its ability to address regulatory concerns without always defaulting to clinical study – particularly relating to the assessment of complex drug-drug interactions (DDIs). Independent validation of simulations against clinical data provides confidence in the results and guides users in adopting best practices.

Although dedicated clinical pharmacology studies can quantify the impact of certain intrinsic or extrinsic factors on drug exposure, it is often not feasible to investigate every possible scenario, especially when there is complex interplay between multiple factors. Demonstration of PBPK modeling capabilities to assess these risks requires robust evidence that simulations can accurately predict the impact of multiple factors and provide meaningful data for both drug developers and regulators.

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