期刊
SEMINARS IN PERINATOLOGY
卷 39, 期 7, 页码 532-536出版社
W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1053/j.semperi.2015.08.007
关键词
drug development; pregnancy; children; drug trials
资金
- National Institute of Child Health and Human Development (NICHD), USA [T32HD043029]
- National Institute of Child Health and Human Development [5U10-HD068258-04]
- National Institute of Allergy and Infectious Disease USA [HHSN272201300017I]
- Centers for Disease Control and Prevention USA [200-2012-53663]
- NIH USA [1R01-HD076676-01A1]
- National Center for Advancing Translational Sciences of the NIH USA [UL1TR001117]
- Novartis Vaccines
- Novavax
- National Institute of Allergy and Infectious Disease [HHSN272201300017I, HHSN272201500006I]
- National Institute for Child Health and Human Development of the NIH [HHSN275201000003I]
- Food and Drug Administration USA [1U01FD004858-01]
- Biomedical Advanced Research and Development Authority (BARDA) [HHSO100201300009C]
- nonprofit organization Thrasher Research Fund
- Durata Therapeutics
Historically, few data exist to guide dosing in children and pregnant women. Multiple barriers to inclusion of these vulnerable populations in clinical trials have led to this paucity of data. However, federal legislation targeted at pediatric therapeutics, innovative clinical trial design, use of quantitative clinical pharmacology methods, pediatric thought leadership, and collaboration have successfully overcome many existing barriers. This success has resulted in improved knowledge on pharmacokinetics, safety, and efficacy of therapeutics in children. To date, research in pregnant women has not been characterized by similar success. Wide gaps in knowledge remain despite the common use of therapeutics in pregnancy. Given the similar barriers to drug research and development in pediatric and pregnant populations, the route toward success in children may serve as a model for the advancement of drug development and appropriate drug administration in pregnant women. (C) 2015 Elsevier Inc. All rights reserved.
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