TABLE 3

Final bootstrap parameter estimates of pharmacokinetic and covariate parameters for plasma and urine dataa

ParameterMedian value95% CIIIV (%)IOV (%)
Intravenous data
    CL (liters/h)20.918.5, 23.4548
    Vc (liters)46.945.1, 49.0208
    Q (liters/h)2.802.47, 3.175718
    Vp (liters)43.137.2, 49.86722
    BSA on Vc1.500.96, 1.96
    Patient status on CL−0.29−0.38, −0.18
    FER10.400.38, 0.4319
    FER20.210.17, 0.2662
    Additive RUV, plasma0.0010.001, 0.002
    Proportional RUV, plasma0.240.22, 0.26
    Additive RUV, urine0.0010.001, 0.154
    Proportional RUV, urine0.330.29, 0.36
Oral data
    F0.750.59, 0.793332
    f1st0.770.77, 0.953936
    Ka (h−1)6.613.19, 6.6133168
    LAG1 (h)0.220.14, 0.243028
    D0 (h)7.777.39, 12.173131
    LAG2 (h)0.540.41, 1.133332
    Proportional RUV0.140.13, 0.24
    Additive RUV0.030.00, 0.03
  • a Median estimates as well as 95% confidence intervals (CIs) of population pharmacokinetic parameters from bootstrap statistics (n = 1,000) based on intravenous (healthy volunteers and patients) and oral (healthy volunteers) data. Shown are percent coefficients of variation for interindividual variability (IIV) and interoccasion variability (IOV). BSA, body surface area (given parameter estimates are exponents of BSA values normalized to a standard individual with a weight of 70 kg and a height of 172 cm); FER, fraction of finafloxacin excreted unchanged renally in healthy volunteers (FER1) and patients (FER2); F, absolute oral bioavailability; f1st, fraction of drug absorbed by a first-order process; Ka, absorption rate constant for a first-order process; LAG1, lag time for a first-order process; D0, duration of a zero-order process; LAG2, lag time of a zero-order process; RUV, residual unexplained variability given a combined additive- and proportional-error model.