Table 2.
Estimates of population pharmacokinetic analysis of clozapine and norclozapine trough plasma levels in schizophrenic patients.
| Parameter | Description | Final model estimate (RSE%) |
Shrinkage | Bootstrap results (n=200) | ||||
|---|---|---|---|---|---|---|---|---|
| Mean | RSE% | Median | 95% CI | |||||
| Population Mean | ||||||||
| CLapCZP (L/h) | Clozapine apparent elimination clearance in nonsmokers | 28.1 (6) | - | 27.8 | 5.6 | 27.8 | 24.7 | 31.1 |
| CLapCZP SMK (L/h) | Clozapine apparent elimination clearance in smokers | 36.5 (8) | - | 36.9 | 7.9 | 36.9 | 30.5 | 42.8 |
| CLapCZP (L/h) | Norclozapine apparent elimination clearance | 53.6 (6) | - | 53.5 | 6.5 | 53.5 | 46.7 | 60.2 |
| F Luverina | Relative bioavailability of Luverina® versus Leponex® | 0.892 (6) | - | 0.895 | 6.8 | 0.896 | 0.769 | 1.02 |
|
| ||||||||
| Between-subject CV | ||||||||
| BSV CLapCZP (%) | 43.3 (12) | 14 | 43.3 | 22 | 43.3 | 31.8 | 53.6 | |
| BSV CLapNCZP (%) | 49.9 (12) | 18 | 50.3 | 26 | 50.4 | 35.9 | 64.2 | |
| BSV F (%) | 43.6 (17) | 26 | 43.9 | 34 | 43.9 | 24.7 | 58.9 | |
| cov CLapCZP - CLapNCZP (%) | 55.7 (30) | - | 34.1 | 26 | 34.1 | 24.0 | 43.2 | |
|
| ||||||||
| Residual variability | ||||||||
| Proportional clozapine (%) | 9.54 (21) | 30 | 9.29 | 27 | 9.52 | 2.97 | 13.4 | |
| Proportional norclozapine (%) | 15.3 (15) | 22 | 15.3 | 16 | 15.2 | 10.8 | 20.3 | |