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. Author manuscript; available in PMC: 2015 Dec 1.
Published in final edited form as: Invest New Drugs. 2014 Jun 15;32(6):1213–1225. doi: 10.1007/s10637-014-0125-2

Table 5.

PK Parameter Estimates After a Single 10 or 20 mg/kg Dose

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