The optimal evaluation and use of antibacterial agents that are very frequently prescribed in neonates during various situations such as early- and late-onset invasive infections depend on adapted dose selection, based on population pharmacokinetic/pharmacodynamic modeling and simulation, using approved surrogate biomarkers as pharmacodynamic end points. Data on efficacy can be extrapolated from adult and pediatric data because of comparable mechanistic action of antibiotics in neonates, children, and adults. However, evaluation of efficacy and toxicity in the neonate should always be discussed with regulatory agencies and are highly recommended when feasible.
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