Table 4.
Population pharmacokinetic parameters for ciclosporin A (CsA) obtained from the bootstrap of the final model. This table shows the mean and coefficient of variation of the pharmacokinetics (PK) parameter estimates as well as the median and percentiles of these estimates. The variability concerns the actual random variability in the PK parameter relative to the population mean value
| PK parameter | Mean value | Variability (%) | CV (%) | Median | Percentiles 2.5–97.5 (%) |
|---|---|---|---|---|---|
| Absorption rate constant (ka, h−1)a | 2.0 | 11 | 2.0 | 1.6 to 2.5 | |
| DDPR ≥ 20 mg | −55%b | −10 | −56% | −66 to 42 | |
| Number of transit compartments | 1 | ||||
| Transit time or lag time (h)a | 1 | ||||
| CsA clearance (L/h) | 15 | 4 | 15 | 14 to 16 | |
| Central volume of distribution (Vc) (L) | 56 | 7 | 57 | 49 to 64 | |
| Peripheral volume of distribution (Vp) (L) | 125 | 10 | 125 | 100 to 149 | |
| Intercompartmental clearance (Q) (L/h) | 14 | 9 | 14 | 12 to 16 | |
| Bioavailability (F): | 0.5 | ||||
| DDPR ≥ 20 mg | −22%b | −13 | −22% | −27 to 16 | |
| IIV absorption rate | 0.09 | 30 | 31 | 0.09 | 0.04 to 0.16 |
| IIV clearance | 0.03 | 17 | 24 | 0.03 | 0.02 to 0.05 |
| IIV central volume of distribution | 0.12 | 35 | 40 | 0.11 | 0.05 to 0.24 |
| IOV bioavailability | 0.02 | 14 | 17 | 0.02 | 0.01 to 0.02 |
| Residual variability | 0.07 | 26 | 10 | 0.07 | 0.06 to 0.09 |
DDPR daily dose prednisolone, SE standard error, CV coefficient of variation, IOV inter-occasion variability; IIV inter-individual variability
aTransit time with one transit compartment is equal to: 1/ka*2
bThese numbers mean a 55% lower value for the absorption rate constant and a 22% lower value for CsA bioavailability