Predicting how medicines get into breast milk

PBPK Modeling & Simulation to Predict Transporter-Mediated Drug Secretion into Human Breast Milk

NIH-funded research University of Washington · NIH-11179280

This project uses computer models to predict which medicines enter breast milk and how much infants might be exposed to.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionUniversity of Washington NIH-funded
Lab location1 site (Seattle, United States)
Project IDNIH-11179280 on NIH RePORTER

What this research studies

The team builds physiologically based pharmacokinetic (PBPK) computer models to simulate drug movement from a nursing mother's blood into breast milk, with a focus on transporter proteins like BCRP/ABCG2. They combine drug chemical properties, breast milk composition and physiology, and data on transporter activity to estimate milk-to-plasma ratios. The models are designed to handle both passive diffusion and active, transporter-mediated secretion that current simple methods miss. Where possible the simulations will be compared with existing human milk and plasma data to refine the predictions.

Who could benefit from this research

Good fit: Ideal participants would be breastfeeding women who are taking prescription or over-the-counter medicines and can provide breast milk samples and medication histories, and possibly blood samples if requested.

Not a fit: People who are not breastfeeding or who do not take medications are unlikely to receive direct benefit from this work.

Why it matters

Potential benefit: If successful, this could help clinicians and breastfeeding mothers choose safer medications by estimating infant exposure without requiring invasive studies for every drug.

How similar studies have performed: Existing methods can predict milk levels for drugs that cross by passive diffusion, but predicting secretion driven by transport proteins is newer and less proven.

Where this research is happening

Seattle, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions Breast Cancer Resistance Protein
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.