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. 2014 Sep 3;16(1):76–84. doi: 10.1208/s12249-014-0194-8

Table III.

Mean Observed and Predicted AUC0–120 h and C max for 120 mg Etoricoxib Tablets for Three Clinical Studies

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