Table 2.
Previously reported DTG pediatric PopPK parameter estimates
| Parameters | Point estimate (%RSE) |
|---|---|
| Apparent clearance, CL/F [l/h] | 1.03 (2.31) |
| Apparent central volume of distribution, V/F [l] | 13.6 (2.42) |
| Absorption rate constant, KA, FCT [h−1] | 0.854 (11.2) |
| Absorption rate constant, KA ~ DT and granules [h−1] | 2.04 (15.7) |
| F, fasted FCT | 1.00 |
| F, without regard to food FCT | 1.10 (3.03) |
| F, fasted DT/granules | 1.53 (3.26) |
| CL/F ~ (WT/70) | 0.455 (4.15) |
| V/F ~ (WT/70) | 0.556 (3.87) |
| CL/F ~ maturation function (FMAT) | |
| Maturation half time, TM50 [PMA weeks] | 52.2 FIX |
| Hill coefficient related to the slope of the enzyme maturation process | 3.43 FIX |
| Interindividual variability | CV% |
| CL/F | 29.4 |
| V/F | 26.4 |
| KA | 107 |
| Interoccasion variability | |
| IOV-CL/F | 33.9 |
| IOV-KA | 91.7 |
| Residual error | |
| Proportional error study P1093 | 28.6% |
| Additive error (μg/ml), study P1093 | 0.00164 |
| Proportional error ODYSSEY | 11.1% |
| Additive error study (μg/ml), ODYSSEY | 0.090 |
DT dispersible tablet; FCT film coated tablet; PMA post-natal age; PMA post-menstrual age
FMAT = (PMAHILL/(PMAHILL + TM50HILL); PMA (weeks) = PNA (years)*52 (weeks) + 40 (weeks). Further details about covariance matrix and full model can be found in the reference [15]