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Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. Addressing the Barriers to Pediatric Drug Development: Workshop Summary. Washington (DC): National Academies Press (US); 2008.

Cover of Addressing the Barriers to Pediatric Drug Development

Addressing the Barriers to Pediatric Drug Development: Workshop Summary.

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References

  1. Budetti P. Ensuring safe and effective medications for children. Journal of the American Medical Association. 2003;290:950–951. [PubMed: 12928474]
  2. FDA (Food and Drug Administration). Drug research in children. FDA Consumer Magazine. 2006. [accessed November 28, 2006]. http://www​.pueblo.gsa​.gov/cic_text/health/testtube/children​.htm
  3. Floren LC, Wiznia A, Hayashi S, Jayewardene A, Stanley K, Johnson G, Nachman S, Krogstad P, Aweeka FT. Pediatric AIDS Clinical Trials Group 377 Protocol Team. Nelfinavir pharmacokinetics in stable human immunodeficiency virus-positive children: Pediatric AIDS Clinical Trials Group Protocol 377. Pediatrics. 2003;112:e220–e227. [PubMed: 12949316]
  4. ICH (International Conference on Harmonization). ICH harmonised tripartite guideline: Clinical investigation of medicinal products in the pediatric population E11. 2000. [accessed January 22, 2007]. http://www​.ich.org/LOB/media/MEDIA487​.pdf Current Step 4 version dated 20 July 2000.
  5. IOM (Institute of Medicine). Making better drugs for children with cancer. Washington, DC: The National Academies Press; 2005.
  6. Jarrett N.Incentives and disincentives for pediatric drug development; Speaker presentation at the Institute of Medicine Workshop on Addressing the Barriers to Pediatric Drug Development; June 13; Washington, DC. 2006.
  7. Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology—drug disposition, action, and therapy in infants and children. New England Journal of Medicine. 2003;349:1157–1167. [PubMed: 13679531]
  8. Mathis L.Growth and development of pediatric drug development at the FDA. Speaker presentation at the Institute of Medicine Workshop on Addressing the Barriers to Pediatric Drug Development; June 13; Washington, DC. 2006.
  9. McKinney RE. Congress, the FDA, and the fair development of new medications for children. Pediatrics. 2003;112:669–670. [PubMed: 12949299]
  10. Roberts R, Rodriguez W, Murphy D, Crescenzi T. Pediatric drug labeling: Improving the safety and efficacy of pediatric therapies. Journal of the American Medical Association. 2003;290(7):905–911. [PubMed: 12928467]
  11. Rodriguez W.What we have learned from the study of drugs under the pediatric initiatives; Speaker presentation at the Institute of Medicine Workshop on Addressing the Barriers to Pediatric Drug Development; June 13; Washington, DC. 2006.
  12. Sugarman J. Determining the appropriateness of including children in clinical research: How thick is the ice? Journal of the American Medical Association. 2004;291:494–496. [PubMed: 14747509]
Copyright © 2008, National Academy of Sciences.
Bookshelf ID: NBK3998

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