Table 2.

Ideal studies in pregnancy and alternative approaches.

Ideal studies	Next best alternatives	Alternate approaches
• Drug exposure studies (Pharmacokinetics over a dosing interval) in first, second, third trimester and post-partum • Drug response studies over a dosing interval (first, second, third trimester and post-partum) • Maternal drug safety assessments (first, second, third trimester and post-partum) • Fetal / Neonatal drug safety assessments (monitoring of neonates and newborn) • Drug excretion in breast milk (total amount excreted in breast milk over a dosing interval)	• Surrogate drug exposure studies (limited sampling strategy or trough level) in first, second, third trimesters and post-partum • Limited drug response studies (first, second, third trimester and post-partum) • Placental (in vitro) perfusion studies • Cord blood sampling for fetal exposure assessments • Milk to plasma ratio for drugs in lactating women • Placental perfusion studies • Placenta on a chip study	• Predictions based on probe drug studies for DME and transporters • Population PK modeling • PBPK modeling and simulations