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Related Concept Videos

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...
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 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...
Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
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...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...

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Related Experiment Video

Updated: May 12, 2026

Making MR Imaging Child's Play - Pediatric Neuroimaging Protocol, Guidelines and Procedure
15:18

Making MR Imaging Child's Play - Pediatric Neuroimaging Protocol, Guidelines and Procedure

Published on: July 30, 2009

Sponsor Initiated Requests to Delay Pediatric Postmarketing Studies.

Susan M Abdel-Rahman1,2, Yutao Gong3, Caleb Choi3

  • 1Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA. susan.abdel-rahman@fda.hhs.gov.

Pharmaceutical Medicine
|May 10, 2026
PubMed
Summary

Delays in mandated pediatric postmarketing studies (PMRs) are increasing due to clinical trial conduct issues, particularly affecting smaller companies. These delays prolong off-label drug use in children, highlighting a need for collaborative solutions.

Related Experiment Videos

Last Updated: May 12, 2026

Making MR Imaging Child's Play - Pediatric Neuroimaging Protocol, Guidelines and Procedure
15:18

Making MR Imaging Child's Play - Pediatric Neuroimaging Protocol, Guidelines and Procedure

Published on: July 30, 2009

Area of Science:

  • Pediatric pharmacology
  • Drug development regulation
  • Clinical trial management

Background:

  • Off-label drug use in children poses significant safety and effectiveness risks due to insufficient pediatric data.
  • Mandated pediatric postmarketing requirement (PMR) studies are crucial for addressing these data gaps.

Purpose of the Study:

  • To analyze the frequency and reasons for delays in completing mandated pediatric PMR studies.
  • To identify factors contributing to extended timelines in pediatric drug development.

Main Methods:

  • Utilized US Food and Drug Administration (FDA) data from 2012-2024 to examine pediatric PMRs and deferral extension (DE) requests.
  • Analyzed PMR completion dates, durations, DE request rationale, sponsor size, and trial enrollment status.

Main Results:

  • Identified 1160 pediatric PMRs, with 459 associated with 1176 DE requests.
  • Observed a decline in issued PMRs but an increase in DE requests, alongside shorter negotiated timelines.
  • Clinical trial conduct issues were the predominant reason for delays (48%), with smaller companies showing higher DE rates and lower success rates.

Conclusions:

  • Increasing DE requests indicate persistent challenges in timely pediatric trial completion.
  • Clinical trial conduct difficulties are the main driver of delays, though root causes require further investigation.
  • Cooperative efforts among regulators, sponsors, and stakeholders are needed to expedite pediatric drug development and reduce off-label use.