Table 3.
Model no. | Model construction a | CV ω2CL/F | CV ω2Vd/F | OBJ (p value) |
---|---|---|---|---|
End of phase II stage (interim analysis)b | ||||
1 | Base model | 19.4% | 18.3% | 356.754 |
2 | CL/F = θ1 + θ2 × (CLCR − 85) | 20.6% | 21.0% | 271.509 (p < 0.001) |
End of phase III stage (final analysis)c | ||||
1 | Base model | 37.4% | 37.0% | 1475.267 |
2 | CL/F = θ1 + θ2 × (CLCR − 85) | 19.5% | 32.4% | 1403.379 (p < 0.001) |
V/F = θ3 | ||||
3 | CL/F = θ1 + θ2 × (CLCR − 85) | 20.6% | 16.4% | 1309.516 (p < 0.001) |
V/F = θ3 × (WT/55) θ4 | ||||
4 | CL/F = θ1 + θ2 × (CLCR − 85) | 20.6% | 16.4% | 1298.040 (p < 0.001) |
V/F = θ3 × (WT/55) θ4 + θ5 × GEN | ||||
5 (final model) | CL/F = θ1 + θ2 × (CLCR − 85) + θ3 × (WT − 55) | 20.1% | 15.8% | 1292.110 (p = 0.015) |
V/F = θ4 × (WT/55) θ5 + θ6 × GEN |
CV, Coefficient of variance; OBJ, objective function value
aCL/F, Total body clearance; V/F, distribution volume/F; GEN, gender (1: male; 0: female); θ, population mean parameters
bFirst-order method (NONMEM version V, level 1.0)
cFirst-order conditional estimation method with interaction (NONMEM version VI, level 2.0)