Most pregnant individuals use prescribed or over-the-counter medications during pregnancy; however, this population has historically been excluded from clinical trials. Therefore, there are important gaps in knowledge about the appropriate dosing for most medications used during pregnancy at the time of approval. In the absence of data, the approved adult dose is typically prescribed to a pregnant individual, but because of the physiologic changes in pregnancy, under dosing or excessive dosing may occur, with potential adverse impacts on safety and efficacy. Further pharmacologic research and collection of PK data during pregnancy are needed to ensure that the appropriate dosing information is available for pregnant individuals. Advancing this field requires identifying key knowledge gaps, barriers to data collection, and potential innovative solutions to improve data generation and analysis.
- Review the general landscape of existing regulatory, scientific, and ethical considerations for drug development in pregnant individuals
- Describe study design considerations for trials collecting PK data in pregnant individuals
- Discuss key aspects of utilizing modeling and simulation to inform study design and dosing considerations for pregnant individuals
- Explore innovative approaches to data generation and analysis in pregnant individuals