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Testing Medications in Children
Abstract
To stimulate more evaluation of the safety and efficacy of medications in children, two federal regulations were established. The pediatric exclusivity provision gives an additional six months of patent protection to companies that voluntarily test a medication in children, whereas the pediatric rule requires pediatric studies if a drug is important for children.
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Citations
Cited by
Allergic Rhinitis and its Impact on Asthma (ARIA) 2008*
Bousquet, J., Khaltaev, N., Cruz, A. A., Denburg, J., Fokkens, W. J., Togias, A., Zuberbier, T., Baena‐Cagnani, C. E., Canonica, G. W., Van Weel, C., et al. (2008) · Allergy · doi:10.1111/j.1398-9995.2007.01620.x · Cited by 4,729
Caldwell, P. H., Murphy, S. B., Butow, P. N., & Craig, J. C. (2004) · The Lancet · doi:10.1016/s0140-6736(04)16942-0 · Cited by 490
Off-Label Use of Drugs in Children
COMMITTEE ON DRUGS, Neville, K. A., Frattarelli, D. A. C., Galinkin, J. L., Green, T. P., Johnson, T. D., MMM, Paul, I. M., & Van Den Anker, J. N. (2014) · Pediatrics · doi:10.1542/peds.2013-4060 · Cited by 391
A literature review on off-label drug use in children
Pandolfini, C., & Bonati, M. (2005) · European Journal of Pediatrics · doi:10.1007/s00431-005-1698-8 · Cited by 346
Children Are Not Just Small Adults: The Urgent Need for High-Quality Trial Evidence in Children
Klassen, T. P., Hartling, L., Craig, J. C., & Offringa, M. (2008) · PLoS Medicine · doi:10.1371/journal.pmed.0050172 · Cited by 209
Metadata
- Authors
- Steinbrook, R.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2002-10-31
- Volume
- 347
- Issue
- 18
- Pages
- 1462-1470
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W1995920385
- Cited by
- 207
- References
- 0
- FWCI
- 15.11
- Type
- journal article
- Language
- en
- Open access
- closed
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- Steinbrook, R. (2002). Testing Medications in Children. New England Journal of Medicine. https://doi.org/10.1056/nejmhpr021646
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.