1. Approximately 50% of breastfeeding women worldwide require medication.
2. Historical exclusion of breastfeeding women from trials is due to concerns over potential risks to infants.
3. The 2019 FDA guidance recommended conducting clinical lactation studies during drug development.
4. Relative Infant Dose (RID) evaluates infant drug exposure through breast milk.
5. Population pharmacokinetic modeling is increasingly used to predict drug transfer into breast milk.
6. Resource limitations in low- and middle-income countries impact lactation research disparities.
7. The Maternal and Infant Lactation PharmacoKinetics program in Uganda seeks to address these disparities.
8. The study emphasizes the need for early-stage lactation studies during drug development for evidence-based medication guidance.

Source: npj Women's Health