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Table 1 Population estimates for the first pediatric PopPK model of rivaroxaban

From: Pharmacokinetics of rivaroxaban in children using physiologically based and population pharmacokinetic modelling: an EINSTEIN-Jr phase I study

Parameter Mean estimate Relative standard error (%)a Inter-individual variability CV (%)b Relative standard error (%) Description
ka for tablet and diluted suspension (1 h− 1) 0.717 21.3 39.7 63.9 Absorption rate constant
ka for undiluted suspension (1 h−1) 0.208 15.4
CL (l h−1) 7.26 9.38 26.2 39.2 Clearance for a subject with a body weight of 70 kg
V (l) 50.9 12 N/A N/A Volume of distribution in the central compartment for a subject with a body weight of 70 kg
Q (l h− 1) 0.928 17.5 N/A N/A Intercompartmental clearance
Vp (l) 13.5 51.5 N/A N/A Volume of distribution in the peripheral compartment
Exponent for CL scaling 0.323 27.1 Exponent to scale CL on the individual body weight
Exponent for V scaling 1 Fixed Exponent to scale V on the individual body weight
F1 0.648 9.03 N/A N/A Relative bioavailability for the rivaroxaban 20 mg-equivalent doses in relation to the rivaroxaban 10 mg-equivalent doses with F1 = 1 per definition
Residual error (%) 46.6 14.1 Proportional residual error
  1. aRelative standard error expressed as a percentage of the estimate; bcoefficient of variation, calculated as the square root of the variance (which is approximately equivalent to coefficient of variation [%])
  2. CL, clearance, CV coefficient of variation, ka absorption rate constant, PopPK population pharmacokinetic, Q first-order inter-compartmental clearance, V volume of distribution Vp peripheral compartment