Clinical DDI Study Design and Quantitative Exposure Prediction – Clinical Biostats

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Washout Periods and Carryover Control

Steady-State DDI Designs and Accumulation

Sparse Sampling and Exposure-Endpoint Bias

Sensitivity of Study Conclusions to Sampling and Assumptions

Separating Parameter, Individual, and Trial Uncertainty

Scheduling Perpetrator Dosing Around Interaction Onset

Sample Size From Within-Subject Variability

Sampling Schedules for AUC and Cmax

Probe Dose Selection for Clinical DDI Studies

Propagating PBPK Uncertainty to Exposure Ratios