Clinical study design strategies to mitigate confounding effects of time-dependent clearance on dose optimization of therapeutic antibodies.

With slow onset (pembrolizumab), the confounding risk is reasonably well controlled using AUC τ from cycles 1–3 with any sample size (Figure 6a,b ), while an increasing trend of risk is seen with large study size using cycle 6 AUC τ (Figure 6c ).

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