An MPRINT HUB virtual workshop: Pharmacokinetic & Pharmacodynamic Study Design in the Postpartum Period workshop was conducted recently.
Pharmacokinetic and pharmacodynamic studies in the postpartum period should include consideration of both the mother and neonate.These studies are complicated by a number of factors including the rapid physiologic changes occurring postpartum in both mother and neonate; variability in delivery methods (e.g. C-section vs vaginal delivery); lactogenesis and breastfeeding; study feasibility/logistic issues; and ethical considerations.
The MPRINT Pharmacometrics and Clinical Trial Design Core hosted this workshop to discuss issues associated with postpartum therapeutic studies to identify gaps in knowledge relating to postpartum PK/PD and provide recommendations to enhance the quality of studies in the postpartum period.
Access the virtual recording below.