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.



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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 (ac- cessed 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 guide- line: Clinical investigation of medicinal products in the pediatric population E11. Cur- rent 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 pre- sentation 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: Im- proving the safety and efficacy of pediatric therapies. Journal of the American Medical Association 290(7):905–911. 

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 ADDRESSING THE BARRIERS TO PEDIATRIC DRUG DEVELOPMENT 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 re- search: How thick is the ice? Journal of the American Medical Association 291:494–496.