Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equi

Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equi

By: Institute of Medicine (author), Board on Health Sciences Policy (author), Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and (author), Thomas F. Boat (editor), Marilyn J. Field (editor)Paperback

Up to 2 WeeksUsually despatched within 2 weeks

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.

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

Product Details

  • ISBN13: 9780309225496
  • Format: Paperback
  • Number Of Pages: 432
  • ID: 9780309225496
  • ISBN10: 0309225493

Delivery Information

  • Saver Delivery: Yes
  • 1st Class Delivery: Yes
  • Courier Delivery: Yes
  • Store Delivery: Yes

Prices are for internet purchases only. Prices and availability in WHSmith Stores may vary significantly

Close