TABLE 2

Noncompartmental parameters of data sets 1 and 2 versus 3a

ParameterData set 1
(n = 10)
Data set 2
(n = 20)b
Pharmacokinetic model
(data sets 1 and 2) (n = 30)
External validation
(data set 3) (n = 20)
P value
(model versus validation)
AUC0–24,ref (mg h/liter)129 (118–191)NA129 (118–191)c105 (86–128)0.028d
AUC0–24,ref/dose (h/liter)0.129 (0.121–0.143)NA0.129 (0.121–0.143)c0.109 (0.088–0.127)0.035d
Cmax (mg/liter)15.6 (11.8–18.5)8.9 (7.2–12.2)10.3 (7.9–15.4)10.5 (7.9–13.0)0.649d
Tmax (h)1 (1–2)2 (2–5)2 (1–2)1 (1–2)0.073d
  • a Data are presented as the median (interquartile range [IQR]).

  • b NA, not applicable.

  • c Only available for data set 1 (n = 10).

  • d Mann-Whitney U test.