Award
Eunice Kennedy Shriver National Institute of Child Health and Human Development 5R01HD105305-05
Physiological-based Pharmacokinetics Approach to Determine the Extent of Drug Exposure of Antiseizure Medications During Pregnancy and Breastfeeding
Recipient
University of Minnesota, Minneapolis, MN, United States
Award Amount
$526,908.00
Ceiling
$526,908.00
Awarded
June 19, 2026
Identifier
5R01HD105305-05
Development and validation of physiologically-based pharmacokinetic models to optimize antiseizure medication dosing during pregnancy and breastfeeding, balancing maternal seizure control with fetal and infant safety.
Description
This project aims to develop and validate physiologically-based pharmacokinetic models to optimize antiseizure medication dosing during pregnancy and lactation, reducing risks to both mother and child. The project uses PBPK methods to characterize drug concentration-time profiles at the tissue level, evaluating target doses needed to achieve optimal drug exposure in women with epilepsy, considering fetal and breastfeeding infant exposure. It involves data from clinical studies, animal data, in vitro studies, and new validation cohorts.