By Development, and Translation Forum on Drug Discovery, Institute of Medicine
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Additional resources for Addressing the Barriers to Pediatric Drug Development: Workshop Summary
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. S. S. S. Food and Drug Administration 9:55 am Discussion 10:25 am Break Incentives and Disincentives for Pediatric Drug Development 10:40 am Ethical Issues Concerning Testing of New Drugs in Children Robert Nelson, MD, PhD Children’s Hospital of Philadelphia 10:55 am Natasha Jarrett ���������������� Hoffmann-LaRoche 11:10 am Thomas Hassall, RPh, MS ������������������� Abbott Laboratories 11:25 am Discussion 12:00 pm Lunch Dose Finding and Bioavailability Guessing 1:00 pm Robert Ward, MD University of Utah 1:15 pm Best Pharmaceuticals for Children Act: Pediatric Formulation Issues George Giacoia, MD National Institute of Child Health and Human Development, National Institutes of Health 1:30 pm Discussion 45 APPENDIX A Could Vaccines Be a Possible Model for Pediatric Drug Development?
Evans has authored more than 300 articles and book chapters, has been the editor of several textbooks and scientific journals, and has received several national awards for his research. He was elected to the Institute of Medicine (IOM) in 2002. George P. Giacoia, MD, is the Program Director of the National Institute of Child Health and Development (NICHD) Pediatric Pharmacology Research Network and the coordinator and planner of the NICHD Pediatric Formulation Initiative. Dr. Giacoia is a neonatologist whose research interest has been in the area of neonatal pharmacology.
In addition, appropriate testing of drug taste and palatability—important to adherence among pediatric populations—is lacking. The science of blocking bitter taste, for example, is in its infancy. Alternatives to oral liquid formulations are needed. One alternative dosing instrument is a patch, but it is difficult to keep a patch on a child unless it is placed on the back, and an occlusive dressing may be needed to keep it in place. In addition, there are major gaps in knowledge regarding different drug delivery systems.
Addressing the Barriers to Pediatric Drug Development: Workshop Summary by Development, and Translation Forum on Drug Discovery, Institute of Medicine