Simcyp PBPK for Drug-Drug Interactions (DDIs): A Regulatory Imperative

Apr 08, 2021

The past two decades have witnessed transformative changes in our approach to using modeling & simulation to assess and manage drug–drug interactions (DDIs). Multidisciplinary innovations in mechanistic assessment of absorption, distribution, metabolism, and excretion (ADME), population pharmacology and pharmacogenetics, physiologically based modeling, and regulatory science have enabled a profound shift in mindset from risk aversion to informative prescribing guidance for optimal risk management1. These advances have resulted in a sea change in how we study and regulate DDIs, as documented in two newly published FDA guidance documents 2,3. In this paper, we focus on how modeling & simulation, specifically physiologically based pharmacokinetics (PBPK) has grown to become an accepted (and encouraged) approach to inform and/or waive DDI studies.

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