Table III.
Clinical study | AUC0–120 h (μg*h/mL) | C max (μg/mL) | ||||
---|---|---|---|---|---|---|
Observed | Predicted | % PE | Observed | Predicted | % PE | |
Protocol 43 | 39.5 | 35.8 | −9.4 | 1.88 | 1.83 | −2.7 |
Protocol 48 | 36.7 | −2.5 | 2.27 | −19.4 | ||
Protocol 70 | 32.9 (MR-4312) | 8.8 | 1.74 (MR-4312) | 5.2 | ||
33.5 (MR-4629) | 6.9 | 1.72 (MR-4629) | 6.4 |
For protocol number 70, predicted and observed data for two different tablet batches MR-4312 and MR-4619 are shown. The % prediction errors (% PE) for these simulations were calculated as ((predicted–observed)/observed) × 100. All the observed clinical data are on Merck file
AUC area under curve, C max maximum plasma concentration