Developmental Pharmacology and Therapeutics in Neonatal Medicine

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).status: publishe