Related Experiment Video
Updated: Aug 25, 2026

Determination of the Transport Rate of Xenobiotics and Nanomaterials Across the Placenta using the ex vivo Human Placental Perfusion Model
Published on: June 18, 2013
Pharmacokinetics in the newborn
Jane Alcorn1, Patrick J McNamara
1College of Pharmacy and Nutrition, University of Saskatchewan, 110 Science Place, SK, S7N 5C9, Saskatoon, Canada. jane.alcorn@usask.ca
Insights
Infant drug safety and efficacy depend on developing pharmacokinetic processes. Understanding these changes in absorption, distribution, metabolism, and excretion is crucial for safe therapeutic exposures in infants.
Area of Science:
- Pharmacology
- Developmental Biology
- Toxicology
Background:
- Infants exhibit different drug responses compared to adults, impacting therapeutic efficacy and safety.
- Immature pharmacokinetic processes in newborns are a primary reason for these variations.
- Physiological and biochemical factors governing drug absorption, distribution, metabolism, and excretion (ADME) undergo significant changes during infant development.
Purpose of the Study:
- To review current data on the growth and maturation of physiological and biochemical factors influencing infant pharmacokinetics.
- To provide insight into how developmental changes alter pharmacokinetic efficiency in infants.
- To clarify dynamic changes in therapeutic efficacy and toxicant susceptibility throughout infancy.
Main Methods:
- Literature review of existing data on infant pharmacokinetic development.
- Analysis of physiological and biochemical changes affecting ADME processes.
- Synthesis of information to explain altered drug responses in infants.
Main Results:
- Significant maturational changes occur in infant absorption, distribution, metabolism, and excretion processes.
- These developmental shifts directly impact the efficiency of pharmacokinetic processes.
- Variations in pharmacokinetic efficiency explain differences in drug efficacy and susceptibility to toxicants.
Conclusions:
- Assessing infant drug safety requires understanding maturational impacts on pharmacokinetics.
- Developmental changes in ADME are key to understanding altered drug responses in infants.
- This knowledge is vital for optimizing therapeutic strategies and managing exposures in the developing infant population.
Abstract:
In addition to differences in the pharmacodynamic response in the infant, the dose and the pharmacokinetic processes acting upon that dose principally determine the efficacy and/or safety of a therapeutic or inadvertent exposure. At a given dose, significant differences in therapeutic efficacy and toxicant susceptibility exist between the newborn and adult. Immature pharmacokinetic processes in the newborn predominantly explain such differences. With infant development, the physiological and biochemical processes that govern absorption, distribution, metabolism, and excretion undergo significant growth and maturational changes. Therefore, any assessment of the safety associated with an exposure must consider the impact of these maturational changes on drug pharmacokinetics and response in the developing infant. This paper reviews the current data concerning the growth and maturation of the physiological and biochemical factors governing absorption, distribution, metabolism, and excretion. The review also provides some insight into how these developmental changes alter the efficiency of pharmacokinetics in the infant. Such information may help clarify why dynamic changes in therapeutic efficacy and toxicant susceptibility occur through infancy.
Related Concept Videos
Pharmacokinetics: Overview
Drug Dosing: Infants and Children
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
Pharmacokinetics in Pediatric Patients: Drug Distribution
Pharmacokinetics in Pediatric Patients: Drug Metabolism
Pharmacokinetics in Pediatric Patients: Drug Excretion

