TABLE 2.

NPAG PK estimates, NCA median values for drug exposure, and simulated exposure values using median population parameter estimatesa

DrugDose (mg)PK estimatesWNL NCA median (range) patient valuesWNL simulations using median NPAG parameter estimates
ka (h−1)kel (h−1)t1/2 (ka, h)t1/2 (kel, h)V/F (liters)V/F (liters/kg)bCL/F (liters/h)CL/F (liters/h/kg)bAUC (μg · h/ml)BiasPrecisionCmax (μg/ml)Tmax (h)AUC0-24,sscCmax (μg/ml)Tmax (h)AUC0-∞
Levofloxacin1,0005.96 (0.76-6.00)0.09 (0.04-0.17)0.12 (0.12-0.91)7.37 (4.14-16.31)81.21 (33.50-114.50)1.28 (0.81-1.83)7.63 (1.49-19.18)0.13 (0.06-0.17)131 (52-702)0.0591.23415.55 (8.55-42.99)1.0 (1.0-4.0)129 (103-358)11.550.7137
Gatifloxacin4000.96 (0.37-6.00)0.13 (0.09-0.16)0.72 (0.12-1.89)5.04 (4.38-7.35)79.25 (58.02-110.54)1.45 (0.91-2.47)10.42 (5.47-17.50)0.18 (0.13-0.30)38 (23-73)−0.1520.2434.61 (3.78-6.40)1.5 (1.0-2.0)43 (32-51)3.692.439
Moxifloxacin4005.95 (1.21-6.00)0.11 (0.07-0.16)0.12 (0.12-0.57)6.53 (4.25-10.57)62.79 (43.59-101.96)1.25 (0.93-1.55)6.66 (2.86-16.64)0.12 (0.10-0.20)60 (24-140)−0.1150.9146.13 (4.47-9.00)1.0 (1.0-2.0)55 (36-79)5.910.758
  • a ka, k-el, and V were estimated directly with NPAG; t1/2 (ka), t1/2 (kel), CL, and AUC were calculated from ka, k-el, and V using standard equations. Values are medians and ranges.

  • b Based on median of individual Bayesian parameters estimates, rather than the original population estimate.

  • c AUC0-24,ss is the equivalent of AUC0-∞.