TABLE 4.
Parameter estimates of hydroxyitraconazole for the final metabolite model of combined single-dose and multidose data
| Parametera | Population estimate | %SE |
|---|---|---|
| CLm/Fm (liters/h) | 45.6 | 1.5 |
| Vmax (liters/h) | 403 | 5.2 |
| Km (ng/ml) | 1.64 | 34.8 |
| CLM5 | −0.208 | 24.4 |
| CLM6 | −0.643 | 5.7 |
| V1m/Fm (liters) | 5.28 | 14.2 |
| BSV (%CV [% shrinkage]) | ||
| BSV (CLm/Fm) | 27.9 (35.2) | |
| RV | ||
| Single-dose studies | ||
| Proportional error (%CV) | 38.7 | 6.1 |
| Additive error (ng/ml) | 0.329 | 38 |
| Multidose studies | ||
| Proportional error (%CV) | 19.6 | 10.4 |
| Additive error (ng/ml) | 0.257 | 8 |
a
CLm/Fm, apparent metabolite clearance; Vmax, maximum elimination rate of the metabolite for the single-dose studies; Km, Michaelis-Menten constant; CLM5 and CLM6, magnitude of reduction in metabolite apparent clearance for studies 10850705 and 10850706, respectively; V1m/Fm, apparent central volume of distribution; BSV, between-subject variability; RV, residual variability.