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Related Concept Videos

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

543
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,...
543
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

941
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...
941
Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

394
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...
394
Drug Dosing: Infants and Children01:29

Drug Dosing: Infants and Children

998
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...
998
Pharmacokinetic–Pharmacodynamic Relationship: Problems01:24

Pharmacokinetic–Pharmacodynamic Relationship: Problems

126
The empirical approach to drug therapy optimization relies on correlating pharmacological response with administered dosage. Such an approach can be costly, time-consuming, and often yields poor correlation due to variables like formulation factors and drug elimination characteristics. A more precise approach correlates response with plasma drug concentration or the amount of drug in the body, rather than dosage. This is achieved through pharmacokinetic-pharmacodynamic (PK/PD) modeling, which...
126

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Persistent pharmacokinetic challenges to pediatric drug development.

Daniel P Sage1, Christopher Kulczar1, Wyatt Roth1

  • 1Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University West Lafayette, IN, USA.

Frontiers in Genetics
|September 16, 2014
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Pediatric drug development faces challenges due to changing pharmacokinetics (PK) and safety concerns, leading to

Keywords:
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Area of Science:

  • Pediatric pharmacology
  • Drug development
  • Pharmacokinetics

Background:

  • Pediatric drug development is hindered by safety concerns, limiting pharmacokinetic (PK) assessments in healthy children.
  • Pediatric patients exhibit dynamic changes in absorption, distribution, metabolism, and excretion (ADME), impacting drug efficacy and safety.
  • Ethical, economic, and technical barriers classify children as 'therapeutic orphans', with insufficient research on their unique drug response.

Purpose of the Study:

  • To review developmental changes in pediatric patients affecting drug pharmacokinetics (PK) and pharmacodynamics (PD).
  • To discuss the impact of these ontogenic changes on drug delivery strategies and therapeutic outcomes.
  • To highlight existing challenges and explore opportunities for improved pediatric drug research and development.

Main Methods:

  • This review synthesizes existing literature on pediatric ADMET (Absorption, Distribution, Metabolism, Excretion, Toxicology).
  • It examines the effects of developmental changes on drug disposition and the potential for toxicological events.
  • The review discusses regulatory incentives and identifies key hurdles and potential solutions in pediatric drug investigation.

Main Results:

  • Significant ontogenic shifts in ADMET processes occur throughout pediatric development, altering drug pharmacokinetics (PK).
  • These dynamic changes can lead to unpredictable drug exposure, resulting in toxic or sub-therapeutic outcomes.
  • Despite regulatory efforts, substantial barriers impede comprehensive PK/ADMET studies in pediatric populations.

Conclusions:

  • Addressing the unique pharmacokinetic and ADMET profiles of pediatric patients is crucial for safe and effective drug therapy.
  • Overcoming research hurdles requires innovative approaches and collaborative efforts to improve pediatric drug development.
  • Further investigation into pediatric pharmacokinetics is essential to mitigate risks and optimize therapeutic outcomes for children.