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Addressing the Barriers to Pediatric Drug Development

By Vanchieri, Cori; Butler, Adrienne; Stith, Knutsen; Andrea, Rapporteurs

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Book Id: WPLBN0003761637
Format Type: PDF eBook :
File Size:
Reproduction Date: 2015

Title: Addressing the Barriers to Pediatric Drug Development  
Author: Vanchieri, Cori; Butler, Adrienne; Stith, Knutsen; Andrea, Rapporteurs
Language: English
Subject: Programming, Medical, Pharmacology
Collections: Technical Books Center
Publication Date:
Publisher: The National Academies Press


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Vanchieri, C., Butler, A., & Rapporteurs, A. (n.d.). Addressing the Barriers to Pediatric Drug Development. Retrieved from

Description: Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the metabolism, renal clearance, other drug disposition mechanisms, and overall response to medications are due to profound anatomical, physiological, and developmental differences. Substantial variation also exists among children of different ages in the ability to metabolize, absorb, excrete, and transform medications. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children—50 to 75 percent—have not been tested in pediatric populations. The younger the age group, the less information is available.

Table of Contents
TOC: Regulatory Framework - Current Challenges in Developing and Prescribing Drugs for Children - Models for Enhancing Pediatric Drug Development - Challenges and Opportunities for the Future - Appendixes.


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