Recent applications of pharmacometrics and systems pharmacology approaches to improve and optimize drug therapy for pregnant and lactating women.

The article discusses the challenges of drug exposure to fetuses and infants during pregnancy and lactation, leading to the exclusion of pregnant and lactating women from clinical trials. Regulatory initiatives like the Diversity Action Plan and E21 Efficacy Guidelines aim to increase inclusion in clinical studies. Pharmacometrics and systems pharmacology play a crucial role in making studies more inclusive and optimizing drug therapy for pregnant and lactating women. The article highlights the importance of robust data on drug exposure, non-clinical safety data, and quantitative applications to inform drug therapy decisions for pregnant and lactating women. [Extracted from the article]