Clinical study design and modeling approaches to study secretion of drugs in human milk

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Breastfeeding offers significant benefits, but medication use in lactating women poses risks due to potential drug transfer to infants.
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Clinical studies in lactating women are essential for understanding drug safety, yet enrollment is challenging due to logistical and ethical concerns.
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Non-clinical models, including in vitro, in vivo, and in silico approaches, can provide insights into drug secretion into human milk.
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The milk-to-plasma ratio (M/P) and relative infant dose (RID) are key pharmacokinetic metrics for assessing drug transfer to human milk.
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Regulatory efforts emphasize the need for including lactating individuals in drug development to improve safety data and study design.

Frontiers In Pediatrics

by Prerna Dodeja, Nupur Chaphekar, Taylor Laffey, Hamdan Albukhaytan, Steve Caritis, Imam Shaik, Raman Venkataramanan
June 17, 2026

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