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Author:   Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) ,  Board on Health Sciences Policy ,  Institute of Medicine ,  Marilyn J. Field
Publisher:   National Academies Press
Imprint:   National Academies Press
ISBN:  

9780309225496

ISBN 10:   0309225493
Pages:   432
Publication Date:   13 October 2012
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

1 Front Matter; 2 Summary; 3 1 Introduction; 4 2 Children's Growth and Development and Pediatric Drug Studies; 5 3 Policy Framework for BPCA and PREA; 6 4 Ethical Issues in Pediatric Drug Studies; 7 5 Safety and Efficacy Assessments in Studies Conducted Under BPCA and PREA; 8 6 BPCA, PREA, and Drug Studies with Neonates; 9 7 Outcomes of Written Requests, Requirements, Studies, and Labeling Changes; 10 8 Pediatric Studies of Biologics; 11 References; 12 Appendix A: Study Activities, Methods, and Public Meetings; 13 Appendix B: Dissemination of Information from Pediatric Studies Conducted Under BPCA and PREA; 14 Appendix C: Biologics in Pediatrics; 15 Appendix D: Biologics Studied and Not Studied in Children; 16 Appendix E: Written Requests for Studies of Pediatric Hypertension: Longitudinal Changes in FDA Specifications; 17 Appendix F: Committee and Staff Biographies; 18 Index

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