Addressing the barriers to pediatric drug development: workshop summary
Gespeichert in:
| Format: | Elektronisch E-Book |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Washington, D.C.
National Academies Press
c2008
|
| Schlagworte: | |
| Online-Zugang: | FAW01 FAW02 Volltext |
| Beschreibung: | 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 children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children--50 to 75 percent-- have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children Includes bibliographical references 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 |
| Beschreibung: | 1 Online-Ressource (xii, 52 p.) |
| ISBN: | 0309107423 0309107431 9780309107426 9780309107433 |
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| 245 | 1 | 0 | |a Addressing the barriers to pediatric drug development |b workshop summary |c 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 |
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| 500 | |a 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 children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children--50 to 75 percent-- have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children | ||
| 500 | |a Includes bibliographical references | ||
| 500 | |a 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 | ||
| 650 | 7 | |a MEDICAL / Chemotherapy |2 bisacsh | |
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| 650 | 4 | |a Pediatrics / Congresses / United States | |
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| 650 | 4 | |a Age Factors | |
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| 650 | 4 | |a Recht | |
| 650 | 4 | |a Pediatric pharmacology |x Research |z United States | |
| 650 | 4 | |a Pediatric pharmacology |x Law and legislation |z United States | |
| 650 | 4 | |a Drugs |x Testing |x Law and legislation |z United States | |
| 650 | 4 | |a Drug development | |
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| 655 | 7 | |0 (DE-588)1071861417 |a Konferenzschrift |2 gnd-content | |
| 700 | 1 | |a Vanchieri, Cori |e Sonstige |4 oth | |
| 700 | 1 | |a Butler, Adrienne Stith |e Sonstige |4 oth | |
| 700 | 1 | |a Knutsen, Andrea |e Sonstige |4 oth | |
| 710 | 2 | |a Institute of Medicine (U.S.) |b Forum on Drug Discovery, Development, and Translation |e Sonstige |4 oth | |
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| spelling | Addressing the barriers to pediatric drug development 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 Washington, D.C. National Academies Press c2008 1 Online-Ressource (xii, 52 p.) txt rdacontent c rdamedia cr rdacarrier 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 children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children--50 to 75 percent-- have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children Includes bibliographical references 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 MEDICAL / Chemotherapy bisacsh Drug Evaluation / standards Drug Design Pediatrics / Congresses / United States Clinical Trials as Topic / standards Age Factors Child Medizin Recht Pediatric pharmacology Research United States Pediatric pharmacology Law and legislation United States Drugs Testing Law and legislation United States Drug development USA (DE-588)1071861417 Konferenzschrift gnd-content Vanchieri, Cori Sonstige oth Butler, Adrienne Stith Sonstige oth Knutsen, Andrea Sonstige oth Institute of Medicine (U.S.) Forum on Drug Discovery, Development, and Translation Sonstige oth http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=247391 Aggregator Volltext |
| spellingShingle | Addressing the barriers to pediatric drug development workshop summary MEDICAL / Chemotherapy bisacsh Drug Evaluation / standards Drug Design Pediatrics / Congresses / United States Clinical Trials as Topic / standards Age Factors Child Medizin Recht Pediatric pharmacology Research United States Pediatric pharmacology Law and legislation United States Drugs Testing Law and legislation United States Drug development |
| subject_GND | (DE-588)1071861417 |
| title | Addressing the barriers to pediatric drug development workshop summary |
| title_auth | Addressing the barriers to pediatric drug development workshop summary |
| title_exact_search | Addressing the barriers to pediatric drug development workshop summary |
| title_full | Addressing the barriers to pediatric drug development 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 |
| title_fullStr | Addressing the barriers to pediatric drug development 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 |
| title_full_unstemmed | Addressing the barriers to pediatric drug development 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 |
| title_short | Addressing the barriers to pediatric drug development |
| title_sort | addressing the barriers to pediatric drug development workshop summary |
| title_sub | workshop summary |
| topic | MEDICAL / Chemotherapy bisacsh Drug Evaluation / standards Drug Design Pediatrics / Congresses / United States Clinical Trials as Topic / standards Age Factors Child Medizin Recht Pediatric pharmacology Research United States Pediatric pharmacology Law and legislation United States Drugs Testing Law and legislation United States Drug development |
| topic_facet | MEDICAL / Chemotherapy Drug Evaluation / standards Drug Design Pediatrics / Congresses / United States Clinical Trials as Topic / standards Age Factors Child Medizin Recht Pediatric pharmacology Research United States Pediatric pharmacology Law and legislation United States Drugs Testing Law and legislation United States Drug development USA Konferenzschrift |
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