1.

Record Nr.

UNINA9910970370203321

Titolo

Addressing the barriers to pediatric drug development : workshop summary / / 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

Pubbl/distr/stampa

Washington, D.C., : National Academies Press, c2008

ISBN

0-309-17865-7

1-281-80023-6

9786611800239

0-309-10743-1

Edizione

[1st ed.]

Descrizione fisica

1 online resource (65 p.)

Altri autori (Persone)

ButlerAdrienne Stith

KnutsenAndrea

VanchieriCori

Disciplina

615.58083

Soggetti

Drugs - Testing - Law and legislation - United States

Pediatric pharmacology - Law and legislation - United States

Pediatric pharmacology - Research - United States

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references (p. 41-42).

Nota di contenuto

""Reviewers""; ""Contents""; ""Summary""; ""1 Introduction""; ""2 Regulatory Framework""; ""3 Current Challenges in Developing and Prescribing Drugs for Children""; ""4 Models for Enhancing Pediatric Drug Development""; ""5 Challenges and Opportunities for the Future""; ""References""; ""Appendixes""; ""Appendix A: Workshop Agenda""; ""Appendix B: Speaker Biographies""

Sommario/riassunto

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.