Table 2.
Population pharmacokinetic parameters estimates with theory-based allometric exponents (100 bootstrap replications)
| Parameter | Description | Unitsa | Bootstrap Estimate (RSE%) |
|---|---|---|---|
| CL | Clearance | L/h/62kg NFM CL | 11.4 (1.1) |
| V1 | Central volume of distribution | L/59kg NFM V | 13.9 (6.6) |
| Q | Inter-compartmental clearance | L/h/62kg NFM CL | 135.2 (7.2) |
| V2 | Peripheral volume of distribution | L/59kg NFM V | 29.9 (3.0) |
| FFATCLb | Fat fraction for clearance | · | 0.509 (42.8) |
| FFATVb | Fat fraction for volume | · | 0.203 (51.6) |
| TM50CL | PMA at 50% maturation | · | 45.7 (4.3) |
| HILLCL | Hill coefficient for maturation | · | 2.3 (9.7) |
| FFEMV | Fractional difference in total volume (V1+V2) in females | · | 1.07 (1.2) |
| FFEMDW | Fractional difference in dosing weight in females | · | 1.08 (1.7) |
| FT1_CL | Fraction of 0–6 h clearance >6 and <36 h | · | 0.932 (1.2) |
| FT2_CL | Fraction of 0–6 h clearance ≥36 h | · | 0.919 (1.4) |
| Between Subject Variability (BSV)a | |||
| TBW | 0.166 (7.8) | ||
| CL | 0.215 (4.7) | ||
| V1 | 0.410 (10.8) | ||
| Q | 0.922 (9.1) | ||
| V2 | 0.120 (23.8) | ||
| Between Occasion Variability (BOV)b | |||
| CL | 0.113 (14.8) | ||
| V1 | 0.244 (20.0) | ||
| Q | 0.577 (24.6) | ||
| V2 | 0.212 (12.4) | ||
| RUVADDc | Additive residual unidentified variability | ng/mL | 26.2 (13.7) |
| RUVPROPc | Proportional residual unidentified variability | · | 0.0387 (12.8) |
a
The NFM of 62 kg for CL and 59 kg for V correspond to allometrically scaled total body weights of 70 kg.
b
Bootstrap estimates for FFATCL and FFATV from ABW available data only.
c
Random effects are expressed as the square root of the estimated variance. BSV and BOV estimates are the apparent coefficient of variation of the variability.