TABLE 3.
Population pharmacokinetic parameters of nelfinavir and M8 and bootstrap validationa
| Parameter | Final model with original dataset mean (CV%) | Bootstrapb
|
|
|---|---|---|---|
| Median | 2.5th-97.5th percentiles | ||
| Structural model | |||
| ka (h−1) | 0.83 (16) | 0.84 | 0.15-1.98 |
| Tlag (h−1) | 0.85 (2) | 0.86 | 0.29-1.74 |
| V (liters) | 596 (23) | 564 | 200-978 |
| CL10 (liters/h) | 35.5 (7) | 34.3 | 29.4-39.7 |
| CL10, θPREG | 0.25 (34) | 0.31 | 0.07-0.84 |
| CL10 and V, θDEL | 2.63 (20) | 2.75 | 1.83-4.16 |
| CL1M (liters/h) | 0.65 (22) | 0.73 | 0.34-2.02 |
| kM0 (h−1) | 3.3 (26) | 3.73 | 1.71-10 |
| kM0, θPREG | 0.51 (33) | 0.50 | 0.18-0.87 |
| kM0, θBW | 1.18 (26) | 1.13 | 0.50-1.76 |
| kM0, θINN | 1.03 (37) | 1.10 | 0.50-3.35 |
| Statistical model | |||
| σNELFI (ng/ml) | 1.17 (13) | 1.15 | 0.96-1.33 |
| σM8 (ng/ml) | 0.27 (24) | 0.26 | 0.20-0.33 |
| ω(V) (%) | 118 (37) | 118 | 59-185 |
| ω(CL10) (%) | 50 (20) | 49 | 36-60 |
| ω(CL1M) (%) | 62 (69) | 63 | 36-84 |
| ω(kM0) (%) | 59 (22) | 58 | 45-72 |
a
CV%, coefficient of variation (standard error of estimate/estimate × 100); ka, absorption rate constant; Tlag, absorption lag time; V, distribution volume of nelfinavir; CL10, nelfinavir elimation clearance; CL1M, nelfinavir-to-M8 formation clearance; kM0, M8 elimination rate constant; kM0, θINN, INN influential factor on kM0; σ, residual variability estimate (CV of residual variability, %); and ω, interindividual variability estimate (CV of intersubject variability, %).
b
Statistics are from 1,000 bootstrap analyses.