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For many therapeutic areas in modern medicine, precision medicine is the current treatment paradigm. Interestingly, or probably disappointingly, the concept of precision medicine often only encompasses selecting the right drug for the right patient. Subsequent selection of the right dose for the right patient is at least equally important and is only scarcely considered. Therapeutic Drug Monitoring (TDM) can be defined as assessing the adequacy of the drug plasma concentrations in relation to a target concentration or concentration window at a specific time in a dosing interval. This evaluation, following appropriate clinical interpretation and according to the drug pharmacokinetic/ pharmacodynamic (PK/PD) properties, can guide dosing. However, finding the optimal dosing in order to guarantee a therapeutic exposure remains complicated. Sources of PK variability, including age, genetic heritage, and disease conditions, all influence the chances of achieving therapeutic outcomes. This aspect is particularly evident in children and neonates where physiological changes, associated with growth and maturation, dramatically influence drug PK properties. Similarly, pediatric patients subjected to medical procedures, including dialysis or extracorporeal membrane oxygenation (ECMO), may require special dose considerations since these procedures could significantly affect PK parameters. In pediatrics, drug-administration issues are more prominent than in adults. To adjust the dose and to secure intake in pediatrics, adult formulations may need to be crushed, dissolved, or extemporaneously prepared as liquid. In the absence of reliable data on these manipulations, TDM may contribute to safe and effective therapy in pediatric practice.
Simeoli et al. (Tue,) studied this question.