Year: 2026 | Month: September | Volume: 13 | Issue: 9 | Pages: 349-360
DOI: https://doi.org/10.52403/ijrr.20260933
Therapeutic Drug Monitoring in Neonates: Clinical Applications, Challenges and Emerging Strategies
Dr. Edwin Dias1, K. Nihara Mahesh2
1Professor and Head, Department of Pediatrics, Director of Research and Publication, Srinivas Institute of Medical Sciences and Research Centre, Mangaluru, India
2PharmD Intern, Department of Pharmacy Practice, Srinivas College of Pharmacy, Mangaluru, India
Corresponding Author: K. Nihara Mahesh
ABSTRACT
Neonates exhibit substantial variability in drug disposition because of ongoing maturation of physiological and biochemical processes, including renal function, hepatic metabolism, body composition, plasma protein binding, and gastrointestinal function. These developmental changes can result in unpredictable drug exposure and make conventional weight-based doing insufficient for achieving optimal therapeutic outcomes. Therapeutic drug monitoring (TDM) provides an individualized approach by integrating measured drug concentrations with pharmacokinetic principles, clinical characteristics, and therapeutic response. This review discussed the pharmacokinetic and pharmacodynamic factors influencing drug disposition in neonates and highlighted the role of therapeutic drug monitoring in optimizing pharmacotherapy in this vulnerable population. The clinical applications of TDM for commonly monitored drugs, including gentamicin, amikacin, vancomycin, phenobarbital, digoxin, and selected antifungal agents, were discussed. The review also examined challenges associated with blood sampling in neonates and emerging approaches such as capillary microsampling, dried blood spot sampling, volumetric absorptive microsampling, and advanced bioanalytical techniques. Variability in neonatal pharmacokinetics, limited neonatal-specific therapeutic ranges, restricted access to monitoring services, and the risk of iatrogenic blood loss remained important challenges. Emerging strategies including population pharmacokinetic modelling, Bayesian forecasting, model-informed precision dosing, pharmacogenomics, and clinical decision-support systems may further enhance individualized drug therapy. Overall, TDM represents an important component of precision pharmacotherapy in neonates and may improve therapeutic efficacy while reducing the risk of drug toxicity.
Keywords: Therapeutic drug monitoring, neonates, pharmacokinetics, pharmacodynamics, precision dosing, microsampling
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