Limited data exists on PK and PD of drugs in pregnancy and post partum. Legal and ethical reasons have contributed to some extent for this. In addition, standard clinical study designs have made it difficult for subjects to participate in these time intensive studies. Modeling and simulation play a critical role in filling the gaps. PBPK modeling and poppk modeling have the ability to make such predictions. Population pk can use small number of samples collected from each subject, but using a large number of such subjects one can identify patient covariates that contribute to observed variability in exposure. Physiological changes in pregnancy can be incorporated in PBPK modeling along with drug characteristics to make exposure predictions. The presentation will identify these aspects and point out current limitations (lack of certain physiological data) that needs to be overcome in order to improve our ability to make such predictions in pregnancy and during postpartum period.
Learning Objectives:
Understand current knowledge base of PK and PD in Pregnant and Postpartum women
Discuss limitations in generating data in pregnant and postpartum subjects
Articulate the application of PBPK and POPPK modeling in understanding drug exposure in pregnant and postpartum subjects
Identify data necessary to improve the performance of modeling and simulations to understand drug exposure and response.
