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Pharmacologic studies in vulnerable populations: Using the pediatric experience.

Publication ,  Journal Article
Zimmerman, K; Gonzalez, D; Swamy, GK; Cohen-Wolkowiez, M
Published in: Semin Perinatol
November 2015

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.

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Published In

Semin Perinatol

DOI

EISSN

1558-075X

Publication Date

November 2015

Volume

39

Issue

7

Start / End Page

532 / 536

Location

United States

Related Subject Headings

  • Vulnerable Populations
  • United States Food and Drug Administration
  • United States
  • Prescription Drugs
  • Pregnant Women
  • Pregnancy
  • Pediatrics
  • Off-Label Use
  • Obstetrics & Reproductive Medicine
  • Maternal-Fetal Exchange
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Zimmerman, K., Gonzalez, D., Swamy, G. K., & Cohen-Wolkowiez, M. (2015). Pharmacologic studies in vulnerable populations: Using the pediatric experience. Semin Perinatol, 39(7), 532–536. https://doi.org/10.1053/j.semperi.2015.08.007
Zimmerman, Kanecia, Daniel Gonzalez, Geeta K. Swamy, and Michael Cohen-Wolkowiez. “Pharmacologic studies in vulnerable populations: Using the pediatric experience.Semin Perinatol 39, no. 7 (November 2015): 532–36. https://doi.org/10.1053/j.semperi.2015.08.007.
Zimmerman K, Gonzalez D, Swamy GK, Cohen-Wolkowiez M. Pharmacologic studies in vulnerable populations: Using the pediatric experience. Semin Perinatol. 2015 Nov;39(7):532–6.
Zimmerman, Kanecia, et al. “Pharmacologic studies in vulnerable populations: Using the pediatric experience.Semin Perinatol, vol. 39, no. 7, Nov. 2015, pp. 532–36. Pubmed, doi:10.1053/j.semperi.2015.08.007.
Zimmerman K, Gonzalez D, Swamy GK, Cohen-Wolkowiez M. Pharmacologic studies in vulnerable populations: Using the pediatric experience. Semin Perinatol. 2015 Nov;39(7):532–536.
Journal cover image

Published In

Semin Perinatol

DOI

EISSN

1558-075X

Publication Date

November 2015

Volume

39

Issue

7

Start / End Page

532 / 536

Location

United States

Related Subject Headings

  • Vulnerable Populations
  • United States Food and Drug Administration
  • United States
  • Prescription Drugs
  • Pregnant Women
  • Pregnancy
  • Pediatrics
  • Off-Label Use
  • Obstetrics & Reproductive Medicine
  • Maternal-Fetal Exchange