Physiologically based pharmacokinetic modelling to predict artemether and lumefantrine exposure in neonates weighing less than 5 kg treated with artemether–lumefantrine to supplement the clinical data from the CALINA study

Based on the success of the PBPK models for artemether and lumefantrine in predicting drug concentrations in adults and children, including neonates, modelling and simulation results can be used with confidence to supplement the limited available data for neonates (1-28 days old) < 5 kg BW obtained from the CALINA study for this rarer and more difficult to recruit patient population.