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

Area of Science:

• Pharmacology
• Regulatory Science
• Maternal-Fetal Medicine

Background:

• Pregnant individuals are often excluded from clinical trials, leading to a lack of data on medication safety, efficacy, and dosing during pregnancy.
• Physiological changes during pregnancy can alter pharmacokinetics, impacting how drugs are absorbed, distributed, metabolized, and excreted.
• This knowledge gap necessitates increased research into drug behavior during pregnancy.

Purpose of the Study:

• To summarize the proceedings of the "Pharmacokinetic Evaluation in Pregnancy" workshop.
• To highlight the need for improved pharmacokinetic research in pregnant populations.
• To emphasize the importance of ensuring appropriate drug dosing for pregnant individuals.

Main Methods:

• A workshop was convened on May 16-17, 2022, bringing together experts.
• The workshop focused on the challenges and methodologies of pharmacokinetic evaluation in pregnancy.
• Proceedings were summarized to capture key discussions and recommendations.

Main Results:

• A significant gap exists in understanding drug pharmacokinetics in pregnant individuals.
• Physiological adaptations during pregnancy necessitate specific pharmacokinetic studies.
• There is a clear need for more data to guide safe and effective medication use.

Conclusions:

• Further research and data collection on pharmacokinetics in pregnancy are essential.
• Regulatory bodies and research institutions must collaborate to address this knowledge deficit.
• Ensuring appropriate drug dosing in pregnant individuals requires dedicated scientific investigation.