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Safe and effective medicines for children : studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act /
"The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and P...
| Clasificación: | Libro Electrónico |
|---|---|
| Autores Corporativos: | , |
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Washington, D.C. :
National Academies Press,
2012.
|
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 245 | 0 | 0 | |a Safe and effective medicines for children : |b studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act / |c Committee on Pediatric Studies Conducted under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equality Act (PREA), Institute of Medicine of the National Academies ; edited by Marilyn J. Field and Thomas F. Boat. |
| 260 | |a Washington, D.C. : |b National Academies Press, |c 2012. | ||
| 300 | |a 1 online resource (xxiii, 408 pages) : |b illustrations (some color) | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | |a Introduction -- Children's growth and development and pediatric drug studies -- Policy framework for BPCA and PREA -- Ethical issues in pediatric drug studies -- Safety and efficacy assessment in studies conducted under BPCA and PREA -- BPCA, PREA, and drug studies with neonates -- Outcomes of written requests, requirements, studies, and labelling changes -- Pediatric studies of biologics. | |
| 520 | |a "The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children"--Publisher's description. | ||
| 588 | 0 | |a Print version record. | |
| 590 | |a ProQuest Ebook Central |b Ebook Central Academic Complete | ||
| 650 | 0 | |a Pediatric pharmacology |x Research |z United States. | |
| 650 | 0 | |a Pediatric pharmacology |x Law and legislation |z United States. | |
| 650 | 0 | |a Drugs |z United States |x Testing. | |
| 650 | 0 | |a Pediatrics. | |
| 650 | 0 | |a Drugs. | |
| 650 | 2 | |a Child Health Services |x legislation & jurisprudence | |
| 650 | 2 | |a Drug Approval |x legislation & jurisprudence | |
| 650 | 2 | |a Drug Industry |x legislation & jurisprudence | |
| 650 | 2 | |a Drug Labeling |x legislation & jurisprudence | |
| 650 | 2 | |a Legislation, Drug | |
| 650 | 2 | |a Patents as Topic |x legislation & jurisprudence | |
| 650 | 2 | |a Pediatrics | |
| 650 | 2 | |a Pharmaceutical Preparations | |
| 650 | 6 | |a Pharmacologie pédiatrique |x Recherche |z États-Unis. | |
| 650 | 6 | |a Médicaments |z États-Unis |x Essais cliniques. | |
| 650 | 6 | |a Pédiatrie. | |
| 650 | 6 | |a Médicaments. | |
| 650 | 7 | |a MEDICAL |x Pharmacology. |2 bisacsh | |
| 650 | 7 | |a Pediatrics |2 fast | |
| 650 | 7 | |a Drugs |2 fast | |
| 650 | 7 | |a Drugs |x Testing |2 fast | |
| 651 | 7 | |a United States |2 fast |1 https://id.oclc.org/worldcat/entity/E39PBJtxgQXMWqmjMjjwXRHgrq | |
| 700 | 1 | |a Field, Marilyn J. |q (Marilyn Jane) |1 https://id.oclc.org/worldcat/entity/E39PCjxm3pQ6GBFrkx6rkvwP73 | |
| 700 | 1 | |a Boat, Thomas F. | |
| 710 | 2 | |a Institute of Medicine (U.S.). |b Committee on Pediatric Studies Conducted under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equality Act (PREA) | |
| 710 | 2 | |a Institute of Medicine (U.S.). |b Board on Health Sciences Policy. | |
| 758 | |i has work: |a Safe and effective medicines for children (Text) |1 https://id.oclc.org/worldcat/entity/E39PCFM3RqGVtqpmbGPBQdPfMd |4 https://id.oclc.org/worldcat/ontology/hasWork | ||
| 776 | 0 | 8 | |i Print version: |t Safe and effective medicines for children. |d Washington, D.C. : National Academies Press, [2012] |z 9780309225496 |w (DLC) 2012472511 |w (OCoLC)812189057 |
| 856 | 4 | 0 | |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=3564276 |z Texto completo |
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