Physiologically-Based Pharmacokinetic Modeling of Trofinetide in Moderate Renal Impairment for Phase 1 Clinical Study Dose Selection with Model Validation.

Correlation of Pharmacokinetic Parameters and Estimated CL cr Statistically significant negative correlations based on Pearson’s coefficients were demonstrated for dose-normalized AUC and CL cr in the moderate renal impairment group but there was a notably lesser degree of correlation for dose-normalized C max and CL cr , which did not reach statistical significance (Table 5 ).

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