Table 3.
Population pharmacokinetic parameters of final models of tacrolimus in children with glomerular disease
| Hao et al93 | Wang et al95 | Wang et al96 | |
|---|---|---|---|
| No. of patients | 28 | 65 | 41 |
| Male/female | 19/9 | 44/21 | 32/9 |
| Age (year) (mean ± SD) | 9.5 ± 4.4 | 7.6 ± 3.9 | 8.05 ± 3.68 |
| Weight (kg) (mean ± SD) | 36.5 ± 17.4 | 30.85 ± 17.12 | 30.53 ± 13.51 |
| Samples (n) | 148 | 147 | 96 |
| Compartment model | One | One | One |
| Typical values | |||
| Ka (h−1) | 5.21 | 4.48 (fixed) | 4.5 (fixed) |
| CL/F (L/h) | 30.9 | 5.46 | 17.7 |
| V/F (L) | 411 | 57.1 | 314 (fixed) |
| Inter‐individual variability (%) | |||
| Ka | 79.1 | … | … |
| CL/F | 43.8 | 22.2 | 31.1 |
| V/F | 99.4 | 0.2 | … |
| Residual variability (%) | 25.9* | 35.9* | 122.5# |
| PPK equation | |||
| CL/F | CL/F = 30.9 × (WT/70)0.75× FCYP3A5; if CYP3A5 *1/*1 and CYP3A5 *1/*3, FCYP3A5 = 1.60; if CYP3A5 *3/*3, FCYP3A5 = 1 | CL/F = 5.46 × EXP(0.0323 × age) × EXP(−0.359 × cystatin‐C) × EXP(0.148 × daily dose of TAC). | CL/F = 17.7 × (WT/70)0.75 × (age/8.30)–0.26 |
CL, clearance; EXP, exponential function; Ka, absorption rate constant; SD, standard deviation; V, volume of distribution.
*Exponential error; #additive error.