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Addressing the Barriers to Pediatric Drug Development:

Workshop Summary

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Status: Available Now

Size: 64 pages, 6 x 9

Publication Year:2008

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PAPERBACK ISBN-10: 0-309-10742-3 ISBN-13: 978-0-309-10742-6	$21.00	$18.90	Add to Cart

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Authors:
Cori Vanchieri, Adrienne Stith Butler, and Andrea Knutsen, Rapporteurs; Forum on Drug Discovery, Development, and Translation; Institute of Medicine
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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 overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few ...
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Table of Contents
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Front Matter	i-xii
Summary	1-6	(skim)
1 Introduction	7-9	(skim)
2 Regulatory Framework	10-19	(skim)
3 Current Challenges in Developing and Prescribing Drugs for Children	20-28	(skim)
4 Models for Enhancing Pediatric Drug Development	29-35	(skim)
5 Challenges and Opportunities for the Future	36-40	(skim)
References	41-42	(skim)
Appendix A: Workshop Agenda	43-45	(skim)
Appendix B: Speaker Biographies	46-52	(skim)

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 overall response to medications are due to profound anatomical, physiological, and developmental differences. 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. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.

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