The Need for Pediatric Drug Development

Robert M. Ward; Daniel K. Benjamin; Jonathan M. Davis; Richard L. Gorman; Ralph Kauffman; Gregory L. Kearns; Mary Dianne Murphy; Catherine M.T. Sherwin

doi:10.1016/j.jpeds.2017.08.011

The Need for Pediatric Drug Development

Robert M. Ward, Daniel K. Benjamin, Jonathan M. Davis, Richard L. Gorman, Ralph Kauffman, Gregory L. Kearns, Mary Dianne Murphy, Catherine M.T. Sherwin

Wright State University

Research output: Contribution to journal › Article › peer-review

Abstract

Therapeutic tragedies in pediatric patients contributed to formulation of the legal requirement that new medications had to be carefully studied before they could be approved for interstate sale. ¹ Despite this, the majority of pediatric patients who require treatment are prescribed medications that are either not approved for pediatric use or contain incomplete directions for pediatric use in the approved product label

Original language	English
Pages (from-to)	13-21
Number of pages	9
Journal	Journal of Pediatrics
Volume	192
DOIs	https://doi.org/10.1016/j.jpeds.2017.08.011
State	Published - Jan 1 2018

ASJC Scopus Subject Areas

Pediatrics, Perinatology, and Child Health

Keywords

BPCA
Institute for Advanced Clinical Trials for Children
International Neonatal Consortium
pediatric clinical trials
pediatric pharmacology
PREA

Disciplines

Medical Specialties
Medicine and Health Sciences
Pediatrics

Access to Document

10.1016/j.jpeds.2017.08.011

Cite this

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title = "The Need for Pediatric Drug Development",

abstract = " Therapeutic tragedies in pediatric patients contributed to formulation of the legal requirement that new medications had to be carefully studied before they could be approved for interstate sale. 1 Despite this, the majority of pediatric patients who require treatment are prescribed medications that are either not approved for pediatric use or contain incomplete directions for pediatric use in the approved product label",

keywords = "BPCA, Institute for Advanced Clinical Trials for Children, International Neonatal Consortium, pediatric clinical trials, pediatric pharmacology, PREA",

author = "Ward, {Robert M.} and Benjamin, {Daniel K.} and Davis, {Jonathan M.} and Gorman, {Richard L.} and Ralph Kauffman and Kearns, {Gregory L.} and Murphy, {Mary Dianne} and Sherwin, {Catherine M.T.}",

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AU - Kearns, Gregory L.

AU - Murphy, Mary Dianne

AU - Sherwin, Catherine M.T.

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AB - Therapeutic tragedies in pediatric patients contributed to formulation of the legal requirement that new medications had to be carefully studied before they could be approved for interstate sale. 1 Despite this, the majority of pediatric patients who require treatment are prescribed medications that are either not approved for pediatric use or contain incomplete directions for pediatric use in the approved product label

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KW - Institute for Advanced Clinical Trials for Children

KW - International Neonatal Consortium

KW - pediatric clinical trials

KW - pediatric pharmacology

KW - PREA

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ER -

The Need for Pediatric Drug Development

Abstract

ASJC Scopus Subject Areas

Keywords

Disciplines

Access to Document

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