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Additional resources for Addressing the Barriers to Pediatric Drug Development: Workshop Summary
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. org/LOB/media/MEDIA487. pdf (accessed January 22, 2007).
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. , 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.
Seizures can occur immediately or up to 24 hours after the therapy is stopped. This information is now on the label for these drugs. • Etodolac (Lodine), used for symptom relief in juvenile rheumatoid arthritis, underwent labeling changes after studies showed that patients aged 6 to 16 years required a higher dose (on a per-kilogram basis) than expected—approximately twice the lower dose recommended for effective treatment in adults. • Labeling changes were made to fluvoxamine (Luvox), a treatment for obsessive-compulsive disorder, to recommend higher doses in adolescents than were previously indicated, with the exception of girls aged 8 to 11, who may require lower doses because the drug can make them drowsy.
Addressing the Barriers to Pediatric Drug Development: Workshop Summary by Development, and Translation Forum on Drug Discovery, Institute of Medicine