Addressing the barriers to pediatric drug development [electronic resource] : workshop summary / Cori Vanchieri, Adrienne Stith Butler, and Andrea Knutsen, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies.
Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that chil...
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| Language: | English |
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Washington, D.C. :
National Academies Press,
c2008.
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| Variant Title: |
Addressing the Barriers to Pediatric Drug Development: Workshop Summary |
| Format: | Electronic eBook |
Contents:
- Introduction
- Response to drugs in various age groups
- Product labeling
- Organization of this summary
- Regulatory framework
- Best pharmaceuticals for children act
- Pediatric Research Equity Act
- Impact of pediatric drug legislation
- Discussion
- Current challenges in developing and prescribing drugs for children
- Barriers to pediatric drug development
- Formulations
- Dosing, bioavailability, and drug response
- Models for enhancing pediatric drug development
- Vaccine development in the United States
- The European Union's new regulatory approach
- The St. Jude's model for pediatric oncology drugs
- Challenges and opportunities for the future
- Systemic solutions
- Elimination of economic barriers
- Concluding thoughts.