Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jun:63 Suppl 1:S7-S17.
doi: 10.1002/jcph.2230.

Pharmacokinetic Evaluation in Pregnancy-Current Status and Future Considerations: Workshop Summary

Daphne Guinn  1 , Leyla Sahin  2 , Elimika Pfuma Fletcher  1 , Su-Young Choi  1 , Tamara Johnson  2 , Miriam Dinatale  2 , Kristie Baisden  2 , Wenjie Sun  2 , Venkateswaran C Pillai  1 , Jose Pablo Morales  3 , Lynne Yao  2
Affiliations

Pharmacokinetic Evaluation in Pregnancy-Current Status and Future Considerations: Workshop Summary

Daphne Guinn et al. J Clin Pharmacol. 2023 Jun.

Abstract

As pregnant individuals have traditionally been excluded from clinical trials, there is a gap in knowledge at the time of drug approval regarding safety, efficacy, and appropriate dosing for most prescription medications used during pregnancy. Physiologic changes in pregnancy can result in changes in pharmacokinetics that can impact safety or efficacy. This highlights the need to foster further research and collection of pharmacokinetic data in pregnancy to ensure appropriate drug dosing in pregnant individuals. Therefore, the US Food and Drug Administration and the University of Maryland Center of Excellence in Regulatory Science and Innovation hosted a workshop on May 16 and 17, 2022, titled "Pharmacokinetic Evaluation in Pregnancy." This is a summary of the workshop proceedings.

Keywords: PBPK; drug development; pregnancy; special populations.

PubMed Disclaimer

References

    1. Centers for Disease Control. Research on Medicines and Pregnancy. https://www.cdc.gov/pregnancy/meds/treatingfortwo/research.html. Updated September 20, 2022. Accessed October 21, 2022.
    1. Lyerly AD, Little MO, Faden R. The second wave: toward responsible inclusion of pregnant women in research. Int J Fem Approaches Bioeth. 2008;1(2):5-22.
    1. Biggio JR, Jr. Research in pregnant subjects: increasingly important, but challenging. Ochsner J. 2020;20(1):39-43.
    1. Andrade SE, Gurwitz JH, Davis RL, et al. Prescription drug use in pregnancy. Am J Obstet Gynecol. 2004;191(2):398-407.
    1. Eke AC. An update on the physiologic changes during pregnancy and their impact on drug pharmacokinetics and pharmacogenomics. J Basic Clin Physiol Pharmacol. 2021;33(5):581-598.

Substances

LinkOut - more resources