Neonatal clinical pharmacology: current evolutions and future perspectives

Pharmacotherapy is a very powerful tool to improve outcome in neonates. Clinical pharmacology supports this by predicting drug-related (side)-effects, driven by pharmacokinetics (PK) and pharmacodynamics (PD). The dynamic changes related to maturation and growth in newborns, combined with population-specific disease characteristics result in a unique setting with extensive variability in both PK (drug concentration-time profiles) and PD (drug concentration-effect profiles). Only in part because of these dynamic alterations, neonatal pharmacotherapy is still lagging behind when compared to the available level of knowledge and research tools in other populations. However, relevant progress has been made. We therefore wanted to highlight some ongoing efforts to ‘translate’ this recently emerged knowledge on neonatal pharmacology by facilitating access for prescribers as an obvious need to improve our current clinical practice. The Neodose project and data driven PK software tools hereby serve as illustrations of such clinical ‘translation’ efforts. This will be followed by some perspectives to further improve neonatal drug development and research tools. Adaptations of research tools to the characteristics of neonates are hereby crucial. The relevance of such adaptations will be highlighted, using physiology-based (PB)-PK modeling and the development of an adverse event severity grading research tool tailored to neonates as examples. In conclusion, neonatal pharmacology is still lagging behind and full catch-up on knowledge driven pharmacotherapy has not yet been attained. However, this subdiscipline is for sure on the move to further improve neonatal outcome, driven by multidisciplinary collaboration.status: publishe