TABLE 4

Measures of midazolam model predictive performance in healthy and cirrhosis populations using three in vitro to in vivo clearance scaling methods after single intravenous bolus and oral doses

Population (Method of Scaling)Intravenous Bolus (7.5 mg Single Dose)Oral (15 mg Single Dose)
AUC_pred (ng⋅h/ml)AUC_obs (ng⋅h/ml)AUCR_pred/AUCR_obsAUC_pred (ng⋅h/ml)AUC_obs (ng⋅h/ml)AUCR_pred/AUCR_obs
Healthy303298a347362
Cirrhosis CP-B and C (CS)5225430.955225760.95
Cirrhosis CP-B and C (CS + SA)5895431.076215761.12
Cirrhosis CP-B and C (EFLV)6315431.146295761.14
  • obs, the observed value from the clinical study (Pentikäinen et al., 1989); pred, the predicted value from the simulation.

  • a Not applicable.