Lessons learned in pediatric clinical research to evaluate safe and effective use of drugs in pregnancy.

Journal Article (Journal Article)

Children and pregnant women are vulnerable populations lacking clinical data to guide drug dosing. For children, over the past 15 years, the knowledge gap in pharmacokinetic, safety, and efficacy data has been narrowed as a result of the use of innovative clinical trial designs, minimal risk research methods, increased understanding of developmental pharmacology, multidisciplinary research teams, increased clinical pharmacology expertise and training, collaborative research networks, and critical legislative changes. This progress has not been observed to a similar degree for pregnant women. These two populations, however, share similar drug development challenges and, therefore, lessons learned in pediatric clinical trials can be leveraged to advance drug development in pregnant women.

Full Text

Duke Authors

Cited Authors

  • Gonzalez, D; Boggess, KA; Cohen-Wolkowiez, M

Published Date

  • April 2015

Published In

Volume / Issue

  • 125 / 4

Start / End Page

  • 953 - 958

PubMed ID

  • 25751205

Pubmed Central ID

  • PMC4372491

Electronic International Standard Serial Number (EISSN)

  • 1873-233X

Digital Object Identifier (DOI)

  • 10.1097/AOG.0000000000000743


  • eng

Conference Location

  • United States