Table 6.

Current gaps in modeling maternal-fetal pharmacology.

Maternal pharmacology

Fetal pharmacology

1. Lack of data on time course of changes in expression and activities of various phase 1 and 2 enzymes during pregnancy and postpartum 2. Lack of data on Time course of changes in various transporters during pregnancy and postpartum 3. Lack of data from same person during and post-delivery 4. Lack of PD measures—Relationship between exposure and response 5. Lack of information on potential impact of other comorbid conditions on PK/PD 6. Lack of PBPK models of biologics

1. Actual fetal exposure / blood and tissue concentration prediction not available—need for validation with meaningful clinical data 2. Lack of data on exposure response relationship in fetus 3. Placental enzymes and transporter expression data to incorporate transplacental transfer in PBPK model 4. Maternal-placental-fetal drug partitioning—factors impacting this such as plasma protein binding in mother, fetus, and role of placental transporters