Addressing the barriers to pediatric drug development
Subtitle: workshop summary
By: Cori Vanchieri, Adrienne Stith Butler, and Andrea Knutsen, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies.
Contributors: Vanchieri, Cori.; Butler, Adrienne Stith.; Knutsen, Andrea.; Institute of Medicine (U.S.). Forum on Drug Discovery, Development, and Translation.
Publisher: National Academies Press
Published: 2008
Place of publication: Washington, D.C
Language: eng
Number of pages: 52
ISBN-13: 9780309107426
Subjects: Pediatric pharmacology -- Research -- United States; Pediatric pharmacology -- Law and legislation -- United States; Drugs -- Testing -- Law and legislation -- United States; Drug Evaluation -- standards -- United States -- Congresses; Pediatrics -- United States -- Congresses
Genres: Congresses
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.
Notes: Includes bibliographical references (p. 41-42).

Also available on the World Wide Web.
Table of contents: title: Introduction; title: Response to drugs in various age groups; title: Product labeling; title: Organization of this summary; title: Regulatory framework; title: Best pharmaceuticals for children act; title: Pediatric Research Equity Act; title: Impact of pediatric drug legislation; title: Discussion; title: Current challenges in developing and prescribing drugs for children; title: Barriers to pediatric drug development; title: Formulations; title: Dosing, bioavailability, and drug response; title: Models for enhancing pediatric drug development; title: Vaccine development in the United States; title: The European Union's new regulatory approach; title: The St. Jude's model for pediatric oncology drugs; title: Challenges and opportunities for the future; title: Systemic solutions; title: Elimination of economic barriers; title: Concluding thoughts.