Neonatology pp 693-707 | Cite as

Developmental Pharmacology and Therapeutics in Neonatal Medicine

  • Karel AllegaertEmail author
  • Janko Samardzic
  • Milica Bajcetic
  • John N. van den Anker
Reference work entry


Knowledge about the safe and effective use of medicines in neonates has increased substantially but resulted in few label changes. Despite the extent of these drug exposures, newborns remain the last therapeutic orphans. Drugs, initially developed for use in adults, are reshaped and tailored to specific neonatal indications. However, neonatal pharmacotherapy not only mirrors adult pharmacotherapy but should be driven by their own specific needs. This is because both pharmacokinetics (absorption, distribution, metabolism, elimination, concentration-time) and pharmacodynamics (concentration-effect) display extensive maturation in early infancy, reflecting maturational physiology. We describe and illustrate the relevance of these maturational changes. We subsequently focus on specific aspects related to therapeutic drug monitoring, the need for population tailored neonatal formulations (including dose flexibility and excipients), and the difficulties related to the recognition of adverse drug reactions in neonates (how to recognize a signal in the noise).



Karel Allegaert is supported by the Fund for Scientific Research, Flanders (fundamental clinical investigatorship 1800214 N), and the research activities are further facilitated by the agency for innovation by Science and Technology in Flanders (IWT) through the SAFEPEDRUG project (IWT/SBO 130033). Janko Samardzic is supported by ERAWEB II scholarship for postdoctoral program at the KU Leuven, Belgium (2014–2015). Milica Bajcetic is supported by the Ministry of Education, Science and Technological Development of the Republic of Serbia (project No 173014) and the European Commission (LENA, 602295). John van den Anker is supported by NIH (K24DA027992, R01HD048689, U54HD071601) and the European Commission (TINN [223614], TINN2 [260908], NEUROSIS [223060]).


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Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Karel Allegaert
    • 1
    • 2
    • 3
    Email author
  • Janko Samardzic
    • 4
    • 5
  • Milica Bajcetic
    • 5
    • 6
  • John N. van den Anker
    • 7
    • 8
    • 3
  1. 1.Neonatal Intensive Care UnitUniversity Hospitals LeuvenLeuvenBelgium
  2. 2.Department of Development and RegenerationKU LeuvenLeuvenBelgium
  3. 3.Intensive Care and Department of Pediatric SurgeryErasmus MC – Sophia Children’s HospitalRotterdamThe Netherlands
  4. 4.Department of Paediatric PharmacologyUniversity Children’s Hospital BaselBaselSwitzerland
  5. 5.Institute of Pharmacology, Clinical Pharmacology and Toxicology, Medical FacultyUniversity of BelgradeBelgradeSerbia
  6. 6.Clinical Pharmacology UnitUniversity Children’s HospitalBelgradeSerbia
  7. 7.Division of Pediatric Clinical PharmacologyChildren’s National Health SystemWashingtonUSA
  8. 8.Departments of Pediatrics, Integrative Systems Biology, Pharmacology and PhysiologyGeorge Washington University, School of Medicine and Health SciencesWashingtonUSA

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