Table 4.
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