Child ; Drug-related side effects and adverse reactions ; Drug therapy ; Infant ; Pharmacokinetics
Abstract
Purpose: Pediatric pharmacotherapy requires a thorough understanding of developmental physiology and the distinct pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of this population. Unlike adults, children (particularly neonates and infants) exhibit substantial differences in drug absorption, distribution, metabolism, and excretion as a result of immature organ function and rapid developmental changes. These characteristics must be considered for safety and efficacy in pediatric pharmacotherapy. Current Concepts: PK differences in children arise from development-dependent factors, including an altered intestinal environment, higher total body water content, immature drug-metabolizing enzyme systems, reduced plasma protein quantity and drug-binding capacity, and limited renal clearance. PD variability relates to age-specific receptor sensitivity and differences in drug response across developmental stages. In addition, children (particularly those younger than 1 year) are more susceptible to adverse drug reactions because of developmental vulnerabilities and the frequent use of off-label medications. Discussion and Conclusion: Optimal pediatric dosing should consider not only chronological age and body weight, but also the maturation of organ systems and metabolic pathways. Practical considerations, including appropriate routes of administration and suitable food vehicles, should be selected according to the child's developmental pharmacological status. Although regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency actively encourage pediatric clinical studies, approved pediatric dosing information remains limited. Therefore, clinicians must rely on fundamental principles of developmental pharmacology and available evidence-based guidelines. A comprehensive understanding of developmental pharmacology, individualized dose adjustment based on developmental PK status, and vigilant monitoring for adverse effects are essential for safe and effective pediatric pharmacotherapy.