Safe and effective medicines for children pediatric 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 PREA an...
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| Format: | Book |
| Language: | English |
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Washington, D.C.
National Academies Press
2012
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| Online Access: | Click Here to View Status and Holdings. |
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| 090 | 0 | 0 | |a QV733 AA1 |b S1281 2012 |
| 245 | 0 | 0 | |a Safe and effective medicines for children |b pediatric 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), Board on Health Sciences Policy, Institute of Medicine of the National Academies ; Marilyn J. Field and Thomas F. Boat, editors |
| 264 | # | 1 | |a Washington, D.C. |b National Academies Press |c 2012 |
| 264 | # | 4 | |c ©2012 |
| 300 | # | # | |a xxiii, 408 pages |b illustrations |c 24 cm |
| 336 | # | # | |a text |b txt |2 rdacontent |
| 337 | # | # | |a unmediated |b n |2 rdamedia |
| 338 | # | # | |a volume |b nc |2 rdacarrier |
| 504 | # | # | |a Includes bibliographic 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 |
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| 650 | 1 | 2 | |a Clinical Trials as Topic |v Congress |x standards |z United States |
| 650 | 2 | 2 | |a Adolescent |v Congress |z United States |
| 650 | 2 | 2 | |a Child |v Congress |z United States |
| 650 | 2 | 2 | |a Drug Approval |v Congress |x legislation & jurisprudence |z United States |
| 650 | 2 | 2 | |a Drug Evaluation |v Congress |x legislation & jurisprudence |z United States |
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| 700 | 1 | # | |a Field, Marilyn J. |e editor |q (Marilyn Jane) |
| 700 | 1 | # | |a Boat, Thomas F., |e editor |
| 710 | 2 | # | |a Institute of Medicine (U.S.). $bCommittee on Pediatric Studies Conducted under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equality Act (PREA) |e issuing body |
| 710 | 2 | # | |a National Research Council (U.S.) |
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A clinical trials manual from the duke clinical research institute lessons from a horse named Jim 
Clinical research and the law