Items in cart [1] Questions? Call 888-624-8373

PAPERBACK list:$21.00 Web:$18.90 add to cart Rights & Permissions Free PDF Access Free Resources Sign in to download PDF book and chapters PDF EXECUTIVE SUMMARY Display this book on your site! Related Titles The Future of Drug Safety: Promoting and Protecting the Health of the Public Emergency Care for Children: Growing Pains Other Related Titles Addressing the Barriers to Pediatric Drug Development: Workshop Summary (2008) Board on Health Sciences Policy (HSP) Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Page 41   E-mail  Facebook  Digg  Stumble  Twitter More The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. References Budetti, P. 2003. Ensuring safe and effective medications for children. Journal of the American Medical Association 290:950–951. FDA (Food and Drug Administration). 2006. Drug research in children. FDA Consumer Magazine. http://www.pueblo.gsa.gov/cic_text/health/testtube/children.htm (accessed November 28, 2006). Floren, L. C., A. Wiznia, S. Hayashi, A. Jayewardene, K. Stanley, G. Johnson, S. Nachman, P. Krogstad, F. T. Aweeka, and Pediatric AIDS Clinical Trials Group 377 Protocol Team. 2003. Nelfinavir pharmacokinetics in stable human immunodeficiency virus-positive children: Pediatric AIDS Clinical Trials Group Protocol 377. Pediatrics 112:e220–e227. ICH (International Conference on Harmonization). 2000. ICH harmonised tripartite guideline: Clinical investigation of medicinal products in the pediatric population E11. Current Step 4 version dated 20 July 2000. http://www.ich.org/LOB/media/MEDIA487.pdf (accessed January 22, 2007). IOM (Institute of Medicine). 2005. Making better drugs for children with cancer. Washington, DC: The National Academies Press. Jarrett, N. 2006. 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, 2006, Washington, DC. Kearns, G. L., S. M. Abdel-Rahman, S. W. Alander, D. L. Blowey, J. S. Leeder, and R. E. Kauffman. 2003. Developmental pharmacology—drug disposition, action, and therapy in infants and children. New England Journal of Medicine 349:1157–1167. Mathis, L. 2006. 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, 2006, Washington, DC. McKinney, R. E. 2003. Congress, the FDA, and the fair development of new medications for children. Pediatrics 112:669–670. Roberts, R., W. Rodriguez, D. Murphy, and T. Crescenzi. 2003. Pediatric drug labeling: Improving the safety and efficacy of pediatric therapies. Journal of the American Medical Association 290(7):905–911. Page 41 Front Matter (R1-R12) Summary (1-6) 1 Introduction (7-9) 2 Regulatory Framework (10-19) 3 Current Challenges in Developing and Prescribing Drugs for Children (20-28) 4 Models for Enhancing Pediatric Drug Development (29-35) 5 Challenges and Opportunities for the Future (36-40) References (41-42) Appendix A: Workshop Agenda (43-45) Appendix B: Speaker Biographies (46-52)

Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 41
Addressing the Barriers to Pediatric Drug Development: Workshop Summary References Budetti, P. 2003. Ensuring safe and effective medications for children. Journal of the American Medical Association 290:950–951. FDA (Food and Drug Administration). 2006. Drug research in children. FDA Consumer Magazine. http://www.pueblo.gsa.gov/cic_text/health/testtube/children.htm (accessed November 28, 2006). Floren, L. C., A. Wiznia, S. Hayashi, A. Jayewardene, K. Stanley, G. Johnson, S. Nachman, P. Krogstad, F. T. Aweeka, and Pediatric AIDS Clinical Trials Group 377 Protocol Team. 2003. Nelfinavir pharmacokinetics in stable human immunodeficiency virus-positive children: Pediatric AIDS Clinical Trials Group Protocol 377. Pediatrics 112:e220–e227. ICH (International Conference on Harmonization). 2000. ICH harmonised tripartite guideline: Clinical investigation of medicinal products in the pediatric population E11. Current Step 4 version dated 20 July 2000. http://www.ich.org/LOB/media/MEDIA487.pdf (accessed January 22, 2007). IOM (Institute of Medicine). 2005. Making better drugs for children with cancer. Washington, DC: The National Academies Press. Jarrett, N. 2006. 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, 2006, Washington, DC. Kearns, G. L., S. M. Abdel-Rahman, S. W. Alander, D. L. Blowey, J. S. Leeder, and R. E. Kauffman. 2003. Developmental pharmacology—drug disposition, action, and therapy in infants and children. New England Journal of Medicine 349:1157–1167. Mathis, L. 2006. 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, 2006, Washington, DC. McKinney, R. E. 2003. Congress, the FDA, and the fair development of new medications for children. Pediatrics 112:669–670. Roberts, R., W. Rodriguez, D. Murphy, and T. Crescenzi. 2003. Pediatric drug labeling: Improving the safety and efficacy of pediatric therapies. Journal of the American Medical Association 290(7):905–911.

OCR for page 42
Addressing the Barriers to Pediatric Drug Development: Workshop Summary Rodriguez, W. 2006. 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, 2006, Washington, DC. Sugarman, J. 2004. Determining the appropriateness of including children in clinical research: How thick is the ice? Journal of the American Medical Association 291:494–496.