Safe and Effective Medicines for Children:

Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act

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Size: 408 pages, 6 x 9

Publication Year:2012

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PAPERBACK ISBN-10: 0-309-22549-3 ISBN-13: 978-0-309-22549-6	$65.00	Add to Cart

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Authors:
Marilyn J. Field and Thomas F. Boat, Editors; Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA); Institute of Medicine
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Table of Contents
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Front Matter	i-xxiv
Summary	1-18	(skim)
1 Introduction	19-42	(skim)
2 Children's Growth and Development and Pediatric Drug Studies	43-62	(skim)
3 Policy Framework for BPCA and PREA	63-88	(skim)
4 Ethical Issues in Pediatric Drug Studies	89-110	(skim)
5 Safety and Efficacy Assessments in Studies Conducted Under BPCA and PREA	111-140	(skim)
6 BPCA, PREA, and Drug Studies with Neonates	141-176	(skim)
7 Outcomes of Written Requests, Requirements, Studies, and Labeling Changes	177-206	(skim)
8 Pediatric Studies of Biologics	207-230	(skim)
References	231-260	(skim)
Appendix A: Study Activities, Methods, and Public Meetings	261-270	(skim)
Appendix B: Dissemination of Information from Pediatric Studies Conducted Under BPCA and PREA	271-284	(skim)
Appendix C: Biologics in Pediatrics	285-320	(skim)
Appendix D: Biologics Studied and Not Studied in Children	321-380	(skim)
Appendix E: Written Requests for Studies of Pediatric Hypertension: Longitudinal Changes in FDA Specifications	381-386	(skim)
Appendix F: Committee and Staff Biographies	387-394	(skim)
Index	395-408	(skim)

Description

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Safe and Effective Medicines for Children:

Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act

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