Table 2. F-ara-A pharmacokinetic parameter estimates of model estimated parameters and bootstrap estimates in the development cohort.
| Parameters | Original Dataset (%RSE) | Bootstrap Estimates (95% C.I.) |
|---|---|---|
| Final Pharmacokinetic Parameters | ||
| Clnr (L/hr) a | 7.04 (14.1%) | 6.95 (5.01-9.01) |
| Clslope (L/hr) a | 3.90 (25.2%) | 4.02 (1.99-5.98) |
| V1pop (L) | 65.9 (2.90%) | 65.9 (62.2- 70.1) |
| Qpop (L/hr) | 9.52 (6.20%) | 9.58 (8.41-10.9) |
| V2pop (L) | 67.2 (6.70%) | 66.7 (56.7-77.5) |
| Between Subject Variability (BSV) | ||
| BSV on Cl | 0.07 | 0.07 (0.04-0.09) |
| CV% =26.5 | CV% =26.4 (20.0-30.0%) | |
| BSV on V1 | 0.06 | 0.06 (0.03-0.09) |
| CV% = 24.5 | CV% =24.5 (17.3-30.0%) | |
| Residual unexplained variability (RUV) | ||
| RUV proportional | 0.05 (15.4%) | 0.05 (0.03-0.07) |
| CV% =22.3 | CV% = 22.3 (17.3-26.5%) | |
| RUV additive | 11.2 ng/ml (27.9%) | 10.5 ng/mL (3.73-16.5) |
a
F-ara-A Clpop is 10.94 L/hr which is a sum of estimate of Clnr (7.09 L/hr) for 70 kg IBW individual and Clslope (3.90 L/hr) for 70 kg IBW individual with CrCl of 85 ml/min.
Clnr: is an estimate of non-renal clearance;
Clslope is an estimate of the change in renal clearance with a unit change in standardized renal function (RenFuncstd);
V1pop: Estimate of typical volume of distribution in central compartment;
Qpop: Estimate of typical inter-compartmental clearance;
V2pop: Estimate of typical volume of distribution in peripheral compartment.