TABLE 2.
Final population pharmacokinetic model parameter estimates.
| Population parameter | Mean estimate of typical value | %RSE of typical value | %BSV | %RSE of BSV | Shrinkage (%) | Bootstrap 95% CI (n = 200) |
|---|---|---|---|---|---|---|
| CL/F, L/hr a | 13.65 | 4.32% | 77.46 | 12.24% | 4.3 | (12.6–14.86) |
| Vc/F, L b | 171 (fixed) | - | 118.78 (fixed) | - | - | - |
| Vp/F, L c | 325 (fixed) | - | 102.09 (fixed) | - | - | - |
| Q/F, L/hr d | 62.46 (fixed) | - | 106.19 (fixed) | - | - | - |
| Ktr, hr-1 e | 4.27 (fixed) | - | 86.44 (fixed) | - | - | - |
| HCTcov effect on clearance | 0.83 | 8.46% | - | - | (0.6–1.03) | |
| RUV – Additive Error (ng/mL) | 2.62 | 12.85% | - | - | (2.45–2.82) |
CL/F: apparent clearance; Vc/F: apparent volume of distribution of the central compartment; Vp/F: apparent volume of distribution of peripheral compartment; Q/F: apparent Inter-compartmental clearance; Ktr: transfer rate; HCTcov: hematocrit exponent estimate on clearance; BSV: between subject variability; RUV: residual unexplained variability; %RSE: percent relative standard error; CI: confidence interval.
The (fixed) parameters use the estimated typical values from the rich sampling study.
a
CL , tvcl * (HCT/(HCT_median)) −HCTcov * (Wt/70)0.75 * eηCL
b
Vc = tvvc * (Wt/70) * eηVc.
c
Vp = tvvp * (Wt/70) * eηVp.
d
Q = tvq * (Wt/70)0.75 * eηQ.
e
Ktr = tvktr * eηKtr.