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Related Concept Videos

Drug Dosing: Infants and Children01:29

Drug Dosing: Infants and Children

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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...
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Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

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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...
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Pharmacokinetics in Pediatric Patients: Drug Distribution01:17

Pharmacokinetics in Pediatric Patients: Drug Distribution

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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,...
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Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

48
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...
48
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

49
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...
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Factors Affecting Drug Response: Overview01:21

Factors Affecting Drug Response: Overview

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When it comes to infants and young children, they are typically administered smaller doses of medication in comparison to adults. This is primarily because their organ functions still need to fully develop, meaning their bodies are not as efficient at metabolizing or eliminating drugs. Additionally, their blood-brain barrier is more permeable than in adults. As a result, high concentrations of drugs can easily penetrate the central nervous system (CNS), potentially leading to neurological...
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Pediatric Dose Selection for Therapeutic Proteins.

Paul R V Malik1, Zaid H Temrikar2, Pierre Chelle1

  • 1School of Pharmacy, University of Waterloo, Waterloo, Ontario, Canada.

Journal of Clinical Pharmacology
|June 29, 2021
PubMed
Summary
This summary is machine-generated.

Selecting pediatric drug doses requires understanding biologic pharmacokinetics. Non-linear weight relationships in children necessitate tiered dosing strategies for therapeutic proteins.

Keywords:
biologicsdose selectionmonoclonal antibodypediatricstherapeutic protein

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Area of Science:

  • Pharmacology
  • Pediatric Drug Development
  • Biologics Pharmacokinetics

Background:

  • Optimizing dosing for monoclonal antibodies and therapeutic proteins in children is complex.
  • Pediatric dosing relies on extrapolating adult data, using pharmacometric approaches.
  • Understanding unique pediatric pharmacokinetic properties is crucial for safe and effective treatment.

Purpose of the Study:

  • To analyze the pharmacokinetic characteristics of therapeutic proteins in pediatric populations.
  • To evaluate the effectiveness of pharmacometric tools in pediatric dose selection.
  • To inform the development of appropriate dosing regimens for pediatric indications.

Main Methods:

  • Utilized allometry, physiologically based pharmacokinetic modeling, and population pharmacokinetic analyses.
  • Analyzed pharmacokinetic and pharmacodynamic data from adult to pediatric extrapolation.
  • Investigated nonlinear relationships between body weight, clearance, and volume of distribution.

Main Results:

  • Identified nonlinear relationships between body weight and clearance (allometric exponent 0.75) and volume of distribution (0.8) for therapeutic proteins in pediatric populations.
  • Observed even higher nonlinearity in newborns and infants (<1 year).
  • Highlighted limitations in the reliability and qualification of some pharmacometric tools for therapeutic proteins.

Conclusions:

  • Pediatric dosing of therapeutic proteins exhibits significant nonlinearity, particularly with respect to body weight.
  • Tiered dosing algorithms based on size or age strata are currently the most practical approach.
  • Further research is needed to refine pharmacometric tools for pediatric biologics dosing.