Table 1.
Schedule of simulated scenarios.
Table 2.
Demographic characteristics of the 6–11 year olds included in the data analysis.
Fig 1.
Time profile of the observed plasma concentrations of rupatadine in 6–11 year olds after the administration of 2.5-mg (crosses) or 5-mg (open circles) doses.
Left panel, observed concentrations of rupatadine in log scale. Right panel, visual predictive check of the final selected model built with data for rupatadine in 6–11 year olds. Solid thin lines cover the area including 90% percentile interval of the simulated plasma concentrations over time, and thick line represents the mean of the simulated profiles. Concentrations have been normalised to a 5-mg dose.
Table 3.
Estimates of the parameters from the base model and final selected model.
Fig 2.
Simulations in children weighing 10, 15, 20 and 24 kg of after a single 2.5-mg dose of rupatadine 1 mg/ml oral solution.
The thin lines mark the boundaries of the area including 98% of the simulated plasma concentrations over time (98% prediction interval), and the thick line represents the mean of the simulated profiles. The horizontal grey line represents the maximum concentration targeted in these children.
Fig 3.
Simulations in children weighing 10, 15, 20 and 24 kg after a single 5-mg dose of rupatadine 1 mg/ml oral solution.
The thin lines mark the boundaries of the area including 98% of the simulated plasma concentrations over time, and the thick line represents the mean of the simulated profiles. The horizontal grey line represents the maximum concentration targeted in these children.
Table 4.
Design optimisation for a study in 2–5 year olds.