TABLE 2.
Final pharmacokinetic model parameters
| Clearance, L/d (RSE%) | 0.608 a | (16) b |
| Volume of distribution, L (RSE%) | 18.2 a | (23) b |
| Effect of anti‐IFX Abs on clearance0 (RSE%) | 0.685 a | (24) b |
| Effect of second/third trimester on clearance c (RSE%) | −0.121 | (56) |
| Interpatient variability in clearance, CV% (RSE%; shrinkage) | 30.7 | (28, 23) |
| Interpatient variability in volume of distribution, CV% (RSE%; shrinkage) | 53.3 | (30, 23) |
| Residual unexplained variability, mg/ml (RSE%; shrinkage) | 0.371 | (13, 6) |
Abbreviations: Abs, antibodies; CV, coefficient of variation; IFX, infliximab; RSE, relative standard error.
a
Parameter value fixed to the final estimate from PK model I.
b
RSE from PK model I.
c
The covariate effects on clearance were defined as: CL = CLtypical* (1 + effect of anti‐IFX Abs on clearance) × (1 + effect of second/third trimester on clearance).