Table 2.

Population PK parameters of the final model and 1000 bootstrap runs

Final population PK model1000 bootstrap run results
Mean valueRSE (%)Shrinkage (%)Median value95% CI
× (1 + (LY/LYmed × 0.8) WTmed = 18 kg, LYmed = 2.2410 ×109/L 
CLpop (L per day) 0.214 11  0.210 0.11-0.32 
Exponent WTmed on CLpop (fixed) 0.75   0.75  
Linear function LYmed on CLpop 0.8 29  0.88 0.09-2.85 
WTmed = 18 kg 
Vdpop (L) 0.985 14  0.994 0.717-1.32 
Exponent WTmed on Vd (fixed)   0.75  
K21/d 2.63 16  2.52 1.33-3.30 
Tmax (mg per day) 22.3 29  22.17 8.49-38.02 
Tm (μg/mL) 2.23 42  2.15 1.25-5.74 
Vmax (mg per day) 0.0438 23  0.0485 0.026-0.255 
Km (μg/mL) 0.633 19  0.605 0.229-8.142 
IIV 
CL (CV%) 74.4 14 73.1 53.5-95.7 
Vd (CV%) 41.5 18 21 42.2 25.6-58.2 
Tm (CV%) 114.5 13 111.9 86.6-144.4 
Km (CV%) 195.4 29 58 162.3 77.0-586.0 
Random residual variability 
Proportional (CV%) 27.9 27.6 24.0-32.4 
Additive (μg/mL) 0.0231 23 0.0225 0.0006-0.034 
Final population PK model1000 bootstrap run results
Mean valueRSE (%)Shrinkage (%)Median value95% CI
× (1 + (LY/LYmed × 0.8) WTmed = 18 kg, LYmed = 2.2410 ×109/L 
CLpop (L per day) 0.214 11  0.210 0.11-0.32 
Exponent WTmed on CLpop (fixed) 0.75   0.75  
Linear function LYmed on CLpop 0.8 29  0.88 0.09-2.85 
WTmed = 18 kg 
Vdpop (L) 0.985 14  0.994 0.717-1.32 
Exponent WTmed on Vd (fixed)   0.75  
K21/d 2.63 16  2.52 1.33-3.30 
Tmax (mg per day) 22.3 29  22.17 8.49-38.02 
Tm (μg/mL) 2.23 42  2.15 1.25-5.74 
Vmax (mg per day) 0.0438 23  0.0485 0.026-0.255 
Km (μg/mL) 0.633 19  0.605 0.229-8.142 
IIV 
CL (CV%) 74.4 14 73.1 53.5-95.7 
Vd (CV%) 41.5 18 21 42.2 25.6-58.2 
Tm (CV%) 114.5 13 111.9 86.6-144.4 
Km (CV%) 195.4 29 58 162.3 77.0-586.0 
Random residual variability 
Proportional (CV%) 27.9 27.6 24.0-32.4 
Additive (μg/mL) 0.0231 23 0.0225 0.0006-0.034 

K21, transfer rate constants connecting compartments; Tmax, maximum transport rate of distribution toward peripheral compartment; Tm, Michaelis–Menten constant saturable distribution toward peripheral compartment; Vmax, maximum elimination rate; Km, concentration at which the elimination pathway is half saturated; CV%, percentage coefficient of variation.

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