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Pharmacokinetics in Pediatric Patients: Drug Excretion

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...

Drug Dosing: Infants and Children

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 Metabolism

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...

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

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...

Pharmacokinetics in Pediatric Patients: Drug Distribution

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...

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Updated: Jun 21, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Leveraging prior quantitative knowledge in guiding pediatric drug development: a case study.

Pravin R Jadhav¹, Jialu Zhang, Jogarao V S Gobburu

¹Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring , MD 20993, USA. Pravin.Jadhav@fda.hhs.gov

Pharmaceutical Statistics

|July 18, 2009

Summary

This study demonstrates how clinical trial simulations (CTS) effectively use prior knowledge to design pediatric trials for anti-hypertensive drugs. This approach ensures appropriate sample size and dose selection for pediatric drug development.

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Last Updated: Jun 21, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Area of Science:

Pharmacology
Clinical Trial Design
Pediatric Drug Development

Background:

Designing pediatric clinical trials requires careful consideration of prior knowledge due to ethical and practical challenges.
Leveraging existing data from adult populations, similar drugs, and general pharmacological principles is crucial for efficient trial design.

Purpose of the Study:

To illustrate the use of clinical trial simulations (CTS) in designing an informative pediatric trial for an anti-hypertensive drug (Drug X).
To demonstrate how prior knowledge from adult data, related pediatric trials, and anti-hypertensive drug development experience can be integrated.
To provide a framework for collaboration between industry and regulatory bodies (FDA) in pediatric trial design.

Main Methods:

Clinical trial simulations (CTS) were employed to design a pediatric trial for Drug X, focusing on sample size and dose range selection.
Various exposure-response scenarios were simulated, informed by the understanding that pediatric populations may differ in responsiveness and sensitivity compared to adults.
Prior knowledge from adult patients, pediatric data of a similar drug (Corlopam), and general anti-hypertensive development experience were utilized.

Main Results:

CTS facilitated objective discussions among inter-disciplinary scientists regarding critical trial design elements.
The simulations supported the selection of an appropriate dose range and sample size for the pediatric trial.
The process aimed to ensure plausible trial designs and rational dosing recommendations for pediatric use.

Conclusions:

Clinical trial simulations (CTS) are a valuable tool for integrating prior knowledge into pediatric trial design.
Collaborative efforts between sponsors and regulatory agencies using CTS can lead to more efficient and informative pediatric drug development.
This case study offers a model for designing pediatric exclusivity trials, optimizing dosing, and generating useful labeling information.