TABLE 4.
Model evaluation for CBD.
AUC (ng·h/ml) | Cmax (ng/ml) | |||||||
---|---|---|---|---|---|---|---|---|
Dose (Epidiolex) | N | Mean observed | Mean predicted | PE (%) | Mean observed | Mean predicted | PE (%) | |
Calibration Datasets | ||||||||
(Taylor et al., 2018) | 1500 mg | 6 | 1470a,b | 1486a | 1.1 | 260b | 214 | −17.7 |
(Taylor et al., 2018) | 6000 mg | 6 | 3490a,b | 3076a | −11.9 | 610b | 453 | −25.7 |
(Tayo et al., 2020) | 200 mg | 8 | 435a,b | 648a | 49.0 | 118b | 87.0 | −26.3 |
Verification Datasets | ||||||||
(Taylor et al., 2019) | 200 mg | 8 | 522a,b | 548a | 5.0 | 96.4b | 86.2 | −10.6 |
(Crockett et al., 2020) | 750 mg | 29 | 1490b | 1526 | 2.4 | 154b | 152 | −1.3 |
(Taylor et al., 2018) | 3000 mg | 6 | 2540a,b | 2608a | 2.7 | 418b | 386 | −7.7 |
(Taylor et al., 2018) | 4500 mg | 6 | 3100a,b | 2968a | −4.3 | 677b | 441 | −34.9 |
Weighted PE (%) | 6.2 | −12.3 |
PK parameters are shown as geometric mean values.
a AUC0-last
b Obtained from a non-compartmental analysis of digitized population-level data due to the discrepancies observed between the reported PK parameters and concentration-time plots.