Related Experiment Video

Updated: Jun 13, 2026

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
08:38

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS

Published on: November 8, 2015

Therapeutic drug monitoring in pediatrics: how do children differ?

Stuart Macleod1

  • 1The Child & Family Research Institute, Vancouver, British Columbia, Canada. smacleod@cw.bc.ca

Therapeutic Drug Monitoring
|May 14, 2010
PubMed

Insights

Therapeutic drug monitoring in children is underdeveloped due to historical neglect in pediatric pharmacology. Children, termed "therapeutic orphans," lack access to optimized drug therapies and research benefits.

Area of Science:

  • Pediatric Pharmacology and Toxicology
  • Clinical Pharmacy

Background:

  • Therapeutic drug monitoring (TDM) in pediatric populations is significantly underdeveloped.
  • Children have historically been excluded from drug research, leading to a lack of optimized therapies and understanding of drug toxicity.
  • The term "therapeutic orphans" was coined in 1968 to highlight this disparity in drug development and access for pediatric patients.

Purpose of the Study:

  • To underscore the underdeveloped state of therapeutic drug monitoring in pediatric populations.
  • To explore the historical reasons behind the neglect of pediatric pharmacology and pharmacy.
  • To discuss the implications of children being considered "therapeutic orphans" in drug development.

Main Methods:

  • Literature review and historical analysis of pediatric drug research and development.
  • Examination of factors contributing to the "therapeutic orphan" status.
  • Identification of drug categories with notable exceptions in pediatric research.

Main Results:

  • Pediatric pharmacology and pharmacy have seen limited progress over the past 50 years compared to other therapeutic areas.
  • Children have not fully benefited from advancements in drug therapy and toxicity understanding.
  • Reasons for this include a shortage of pediatric drug research and limited commercial interest from private sector sponsors.

Conclusions:

  • The field of therapeutic drug monitoring in children requires significant advancement.
  • Addressing the "therapeutic orphan" issue is crucial for equitable access to modern medicine for pediatric populations.
  • Targeted research and development are needed to improve drug efficacy and safety in children.

Related Concept Videos

Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses a challenge in...
Drug Dosing: Infants and Children01:29

Drug Dosing: Infants and Children

Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
Pharmacokinetics in Pediatric Patients: Drug Distribution01:17

Pharmacokinetics in Pediatric Patients: Drug Distribution

Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight, compared...
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...