Catalogue


Safe and effective medicines for children : pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act /
Committee on Pediatric Studies Conducted under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equality Act (PREA), Institute of Medicine of the National Academies; Board on Health Scienbces Policy;Marilyn J. Field and Thomas F. Boat, editors.
imprint
Washington, D.C. : The National Academies Press, [2012], c2012
description
xxiii, 408 p. : ill. ; 24 cm
ISBN
0309225493 (pbk.), 9780309225496 (pbk.)
format(s)
Book
Holdings
More Details
imprint
Washington, D.C. : The National Academies Press, [2012], c2012
isbn
0309225493 (pbk.)
9780309225496 (pbk.)
contents note
Introduction -- Children's growth and development and pediatric drug studies -- Policy framework for BPCA and PREA -- Ethical issues in pediatric drug studies -- Safety and efficacy assessment in studies conducted under BPCA and PREA -- BPCA, PREA, and drug studies with neonates -- Outcomes of written requests, requirements, studies, and labelling changes -- Pediatric studies of biologics.
catalogue key
8780262
 
Includes bibliographical references and index.
A Look Inside
Summaries
Description for Bookstore
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.

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