Table 3.
Comparison of predicted and observed morphine pharmacokinetics parameters in healthy adults
| PK parameters (mean ± SD) a | ||
|---|---|---|
| Model development | AUC∞ (ng/mL*hr) | CL (mL/min/kg) |
| Prediction | 49.4 ± 10 | 17.7 ± 3.8 |
| Observed (n = 6)18 | 45.9 ± 7.7 b | 17.9 ± 7.3 c |
| Ratio d | 1.1 | 0.99 |
| PK parameters (mean ± SD) a | ||
| Model verification | AUC∞ (nM*hr/70 kg) e | CL (mL/min/70kg)e |
| Prediction | 352 ± 133 | 1,232 ± 260 |
| Observed (n = 6)25 | 290 ± 67 | 1,584 ± 408 |
| Ratio | 1.2 | 0.78 |
AUC∞, area under the curve to infinity; CL, clearance; PK, pharmacokinetic.
aMean ± SD of total of 402 simulations (67 virtual trials with 6 subjects). bAUC was corrected for the actual free‐based dose. cCL estimate based on dose as morphine base. dRatio of predicted to observed data. ePredicted PK parameters were normalized to 70 kg because reported PK parameters were standardized to a weight of 70 kg.