Affiliation:
1. Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA
2. Division of Pediatric and Maternal Health Office of Drug Evaluation IV Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA
3. Office of Clinical Policy Office of the Commissioner US Food and Drug Administration Silver Spring Maryland USA
Abstract
AbstractAs 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.
Subject
Pharmacology (medical),Pharmacology
Cited by
5 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献