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. 2011 Jul 28;68(1):39–53. doi: 10.1007/s00228-011-1095-3

Table 4.

Final population pharmacokinetics parameters for garenoxacin

Parameter End of phase II stagea End of phase III stageb Bootstrap (n =1,000)c
Model 2 Final model
CL/F (ml/min) CL/F = θ1 + θ2 × (CLCR − 102) CL/F =  θ1 +  θ2 × (CLCR − 85) +  θ3 × (WT −  55)
  θ1 66.7 ± 1.7 64.3 ± 1.25 65.3 (62.2 –76.3)
  θ2 0.167 ± 0.036 0.213 ± 0.0309 0.184 (0.109 –0.261)
  θ3 0.276 ± 0.113 0.328 (0.090–0.540)
V/F (l) V/F = θ4 V/F = θ4× (WT/55) θ5 +  θ6 × GEN
  θ4 61.8 ± 1.7 53.9 ± 1.89 55.4 (49.8–68.4)
  θ5 0.739 ± 0.104 0.502 (0.195 –0.873)
  θ6 6.98 ± 1.88 8.02 (3.85–10.56)
  ka (1/h) 4.72 ± 0.54 2.14 ± 0.223 2.16 (1.69–2.99)
Coefficent of variance Coefficient of variance
Inter-individual variability Inter-individual variability
  ωCL/F 2 0.0424 ± 0.0097 20.6% 0.0403 ± 0.00748 20.1% 0.0374 (0.0149–0.0673)
  ωV/F 2 0.0443 ± 0.0132 21.0% 0.0249 ± 0.00585 15.8% 0.156 (0.0181–0.3915)
  ωCL/F,V/F 0.0330 ± 0.0115 0.0292 ± 0.00618 0.0096 (0.0036–0.0385)
(r d = 0.761) (r = 0.922)
  ω2ka 2.63 ± 0.56 162% 0.411 ± 0.0863 64.1% 0.470 (0.269–1.073)
Intra-individual variability Intra-individual variability
  σ2 0.0645 ± 0.0057 25.4% 0.105 ± 0.0060 32.4% 0.113 (0.095–0.162)

ka, First-order absorption rate constant

aFirst-order method (NONMEM version V, level 1.0). Data are presented as the estimated value ± standard error

bFirst-order conditional estimation method with interaction (NONMEM version VI, level 2.0). Data are presented as the estimated value ± standard error

cData presented as median, with the 5−95% percentiles in parenthesis

d r, Correlation coefficient