TABLE 1

Patient characteristics of the study population used for development of pharmacokinetic model versus external validationa

ParameterData set 1
(n = 10)
Data set 2
(n = 20)
Pharmacokinetic model
(data sets 1 and 2) (n = 30)
External validation
(data set 3) (n = 20)
P value
(model versus validation)
Sex (no. [%])
    Male8 (80)12 (60)20 (67)12 (60)0.765b
    Female2 (20)8 (40)10 (33)8 (40)
Age (yr)43.5 (41.5–47.0)38.5 (31.3–48.0)41.5 (33.5–48.0)30.5 (25.5–34.8)0.002c
Ht (m)1.69 (1.60–1.76)1.68 (1.63–1.74)1.69 (1.61–1.75)1.74 (1.66–1.82)0.038c
Wt (kg)55.5 (50.1–60.8)51.5 (43.7–59.7)54.6 (47.9–59.9)63.4 (53.8–78.5)0.001c
Dose (mg/kg of body wt)18.0 (16.5–20.0)14.6 (12.8–17.2)15.7 (13.6–18.1)15.8 (12.8–16.6)0.348c
BMI (kg/m2)19.4 (18.7–21.2)18.3 (16.1–21.4)18.9 (17.5–21.2)20.6 (18.9–25.6)0.016c
Serum creatinine concn
(µmol/liter)
80 (67–93)73 (67–80)74 (68–87)66 (59–72)0.014c
  • a Data are presented as the median (interquartile range [IQR]) unless otherwise stated.

  • b Fisher’s exact test.

  • cMann-Whitney U test.