Therapeutic drug monitoring in neonates

Arch Dis Child. 2016 Apr;101(4):377-81. doi: 10.1136/archdischild-2013-305309. Epub 2016 Jan 22.


Therapeutic drug monitoring (TDM) aims to integrate drug measurement results into clinical decision making. The basic rules apply when using TDM in neonates (aminoglycosides, vancomycin, phenobarbital, digoxin), but additional factors should also be taken into account. First, due to both pharmacokinetic variability and non-pharmacokinetic factors, the correlation between dosage and concentration is poor in neonates, but can be overcome with the use of more complex, validated dosing regimens. Second, the time to reach steady state is prolonged, especially when no loading dose is used. Consequently, the timing of TDM sampling is important in this population. Third, the target concentration may be uncertain (vancomycin) or depend on specific factors (phenobarbital during whole body cooling). Finally, because of differences in matrix composition (eg, protein, bilirubin), assay-related inaccuracies may be different in neonates. We anticipate that complex validated dosing regimens, with subsequent TDM sampling and Bayesian forecasting, are the next step in tailoring pharmacotherapy to individual neonates.

Keywords: Neonatology; Pharmacology; Toxicology.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Anti-Bacterial Agents / administration & dosage
  • Anticonvulsants / administration & dosage
  • Bayes Theorem
  • Dose-Response Relationship, Drug*
  • Drug Monitoring / methods*
  • Humans
  • Infant, Newborn
  • Phenobarbital / administration & dosage
  • Vancomycin / administration & dosage


  • Anti-Bacterial Agents
  • Anticonvulsants
  • Vancomycin
  • Phenobarbital