Pharmacologic studies in vulnerable populations: Using the pediatric experience.

Journal Article (Journal Article;Review)

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.

Full Text

Duke Authors

Cited Authors

  • Zimmerman, K; Gonzalez, D; Swamy, GK; Cohen-Wolkowiez, M

Published Date

  • November 2015

Published In

Volume / Issue

  • 39 / 7

Start / End Page

  • 532 - 536

PubMed ID

  • 26358805

Pubmed Central ID

  • PMC4628576

Electronic International Standard Serial Number (EISSN)

  • 1558-075X

Digital Object Identifier (DOI)

  • 10.1053/j.semperi.2015.08.007


  • eng

Conference Location

  • United States