Table 1:Bayesian Parameter Based Exposure Estimates at Cycle 6

MYL-1401O (N=245)Herceptin®(N=240)Total(N=485)
Parametern*213202415
Dose (mg)Mean (SD)420.70 (90.46)421.25 (97.67)420.97 (93.92)
Clearance (L/day)0.27 (0.10)0.28 (0.08)0.27 (0.09)
Volume of Central Compartment (L)3.16 (0.60)3.20 (0.60)3.18 (0.60)
Volume at Steady State (L)6.36 (1.19)6.32 (1.14)6.34 (1.16)
AUC (ug*day/mL)40501.40 (13037.04)38816.90 (11966.26)39681.40 (12540.58)
Dose-normalized AUC (ug*day/mL/mg)98.50 (30.56)94.41 (28.90)96.51 (29.80)
Cmax,ss (ug/mL)177.00 (37.76)171.52 (34.61)174.33 (36.32)
Dose-normalized Cmax,ss (ug/mL/mg)0.43 (0.10)0.42 (0.09)0.43 (0.10)
Half-life (day)Median (SD)25.12 (7.50)24.34 (6.89)24.74 (7.21)
  • *concentrations below lower limit of quantification and samples before first dose with values >zero were excluded from Pop PK analysis, as were some patients with incomplete information for covariates significant in the final model.