Pregnant and lactating women have historically been excluded from clinical trials, limiting data on drug pharmacokinetics, safety, and efficacy in these populations. This knowledge gap stems from complex ethical, historical, and cultural factors, which previously categorized these women as vulnerable rather than protected participants. Recent legislative frameworks, including the FDA Pregnancy and Lactation Labeling Rule, have catalyzed efforts to include these populations in structured research. Quantitative pharmacology approaches using innovations such as physiologically based pharmacokinetic models support optimized trial designs, safer dosing regimens, and ethical research frameworks. Emerging technologies, including artificial intelligence, novel drug delivery mechanisms, and organ-on-chip models, further enhance insights into maternal-fetal drug exposure and drug exposures in breastfeeding infants. Integrating in vitro, ex vivo, in vivo, and clinical data and modeling approaches improves understanding of pregnancy-related physiological changes and their impact on drug outcomes, ultimately enabling appropriate and equitable pharmacotherapy for pregnant and breastfeeding women.
Otieno et al. (2026) studied this question.