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Therapeutic Orphans

All medicines should be administered with two aims in mind: to effectively treat a specific disease and to avoid disproportional side effects. But the effects of a medicine given to a newborn baby can vary drastically compared with adults and even other pediatric populations. There is a recognized need worldwide for more research relating to medicinal products and neonates, but despite this, it is still common practice to prescribe medicines to newborns off label. The prescription is often made by extrapolating from the dosing regimens and indications validated in other pediatric populations – and rarely on neonatal pathophysiology.

Clinical pharmacology aims to predict drug-specific (side) effects based on pharmacokinetics and pharmacodynamics. Many of you will be aware that pharmacokinetic studies estimate the relationship between a drug concentration at a specific site and time (looking at what the body does to the drug), whereas pharmacodynamic (PD) studies estimate the relationship between a drug concentration and (side) effects (what the drug does to the body). Because of physiology-related maturation in absorption, distribution, metabolism, and excretion (ADME) processes, pharmacokinetics in newborns and early infancy are very different to other patient groups. Body composition, protein binding and compartment sizes all change during infancy, as well as the metabolic processes for breaking down drugs. Similarly, renal function also displays age-dependent clearance. Age-dependent PD differences have not been well explored, but are known to relate to age-dependent effects or side effects.

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