عنوان

Addressing the barriers to pediatric drug development :

(Number (ISBN

0309107431

(Number (ISBN

1281800236

(Number (ISBN

9780309107433

(Number (ISBN

9781281800237

Erroneous ISBN

0309107423

Erroneous ISBN

9780309107426

Number

b708213

Title Proper

Addressing the barriers to pediatric drug development :

General Material Designation

[Book]

Other Title Information

workshop summary /

First Statement of Responsibility

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.

Place of Publication, Distribution, etc.

Washington, D.C. :

Name of Publisher, Distributor, etc.

National Academies Press,

Date of Publication, Distribution, etc.

©2008.

Specific Material Designation and Extent of Item

1 online resource (xii, 52 pages)

Text of Note

Includes bibliographical references.

Text of Note

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

0

Text of Note

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.

Title

Addressing the barriers to pediatric drug development.

International Standard Book Number

9780309107426

Drug development.

Drugs-- Testing-- Law and legislation-- United States.

Pediatric pharmacology-- Law and legislation-- United States.

Pediatric pharmacology-- Research-- United States.

Age Factors.

Child.

Clinical Trials as Topic-- standards.

Drug Design.

Drugs, Evaluation-- standards.

Pediatrics-- United States, Congresses.

Drug development.

Drugs-- Testing-- Law and legislation.

MEDICAL-- Chemotherapy.

United States.

7

M

MED-- 012000

Number

Edition

Class number

Book number

Class number

Class number

Book Number

Butler, Adrienne Stith.

Knutsen, Andrea.

Vanchieri, Cori.

Institute of Medicine (U.S.)., Forum on Drug Discovery, Development, and Translation.

Date of Transaction

20201207231156.0

Cataloguing Rules (Descriptive Conventions))

pn

Electronic name

[Book]

Y