Dosing Regimen Selection and Simulated Datasets
To avoid nemonoxacin accumulation in the patients with impaired kidney function, the standard dosage (0.5 g q24h) should be adjusted by reducing the maintenance dose and/or prolonging the dosing interval. Four dosing regimens (0.25 g q24h, loading dose of 0.5 g on Day 1 followed by maintenance dose (MD) of 0.25 g q24h, 0.5 g q24h, and 0.5 g q48h) of nemonoxacin were compared in 1000 virtual subjects simulated from the final PPK parameters using the original dataset. Descriptive statistics (arithmetic mean, geometric mean, and variation) of the peak levels and AUC0 -24h of nemonoxacin were obtained accordingly for PK/PD analysis.