Assessing the Efficiency of Mixed Effects Modeling in Quantifying Metabolism-based Drug-drug Interactions: Using In Vitro Data as an Aid to Assess Study Power

The clinical assessment of metabolic drug-drug interactions (mDDI) may involve population-based pharmacokinetic (POPPK) assessment as part of Phase 3 clinical trials. The elements of such POPPK study design have not been linked to prior information from in vitro experiments. Using in vitro-in vivo extrapolation techniques, implemented within Simcyp algorithms, the influence of POPPK study design […]

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