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

The article “Recent Applications of Pharmacometrics and Systems Pharmacology Approaches to Improve and Optimize Drug Therapy for Pregnant and Lactating Women” by Priya Jayachandran, Jane Knöchel, Brian Cicali, and Karen Rowland Yeo, highlights the need for comprehensive drug exposure data in pregnant and lactating women, who have been historically underrepresented in clinical trials. Recent regulatory initiatives by the FDA and ICH are promoting greater inclusion of these populations. The article emphasizes the role of pharmacometrics and systems pharmacology (PSP), particularly physiologically-based pharmacokinetic (PBPK) modeling, in optimizing drug therapy and ensuring safety. It also discusses the importance of non-clinical safety data and predictive models for estimating drug transfer into breast milk, advocating for more inclusive and informed drug development strategies.