Table 5.
Subject | Dose mg/kg | Rsq adjusted | # points lambda z | Lambda z lower day | Lambda z upper day | HL day | Tmax day | Cmax μg/mL | Cmax/Dose kg*μg/mL/mg | AUC day*μg/mL | AUC/dose day*kg*μg/mL/mg | V mL/kg | CL mL/day/kg |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1104 | 10 | 0.9766 | 3 | 154.2 | 259 | 10.49 | 42.20 | 681.0 | 68.10 | 37,903 | 3,790 | 26.45 | 1.748 |
1301 | 10 | 0.9902 | 4 | 167.2 | 226 | 11.14 | 42.20 | 257.0 | 25.70 | 18,360 | 1,836 | 55.80 | 3.471 |
1302 | 10 | 0.9998 | 3 | 169.2 | 199 | 12.03 | 155.20 | 337.9 | 33.79 | 23,765 | 2,377 | 43.14 | 2.486 |
1901 | 10 | 0.9989 | 3 | 161 | 226 | 15.10 | 42.20 | 495.81 | 49.58 | 32,920 | 3,292 | 36.41 | 1.672 |
Mean | 12.19 | 442.9 | 44.29 | 28,237 | 2,824 | 40.45 | 2.34 | ||||||
STD | 2.04 | 187.1 | 18.71 | 8,811 | 881 | 12.32 | 0.84 | ||||||
CV% | 16.74 | 42.3 | 42.3 | 31.2 | 31.2 | 30.5 | 35.7 | ||||||
1105 | 20 | 0.8425 | 3 | 56.2 | 114 | 18.80 | 14.00 | 720.569 | 36.03 | 23,887 | 1,194 | 54.49 | 2.009 |
1107 | 20 | 0.9618 | 3 | 162.2 | 220 | 10.76 | 27.20 | 652.373 | 32.62 | 45,822 | 2,291 | 38.75 | 2.495 |
1902 | 20 | 0.9065 | 4 | 154.2 | 203 | 13.30 | 154.20 | 1,100.950 | 55.05 | 63,145 | 3,157 | 24.44 | 1.274 |
Mean | 14.29 | 824.6 | 41.23 | 44,285 | 2,214 | 39.23 | 1.93 | ||||||
STD | 4.11 | 241.7 | 12.09 | 19,674 | 984 | 15.03 | 0.62 | ||||||
CV% | 28.75 | 29.3 | 29.3 | 44.4 | 44.4 | 38.3 | 31.9 |
Abbreviations: STD, Standard deviation; CV%, Coefficient of variation; RSQ adjusted, Goodness of fit statistic for the terminal elimination phase adjusted for the number of points used in the estimation of λz; # points lambda z=number of points in the terminal elimination phase used to calculate λz; HL, apparent terminal elimination half life; Tmax, Time to reach Cmax; Cmax, Maximum observed concentration, occurring at Tmax; Cmax/Dose, Maximum observed concentration normalized by dose; V, volume of distribution based on the terminal phase; CL, systemic clearance; AUC, area under the concentration-time curve