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Drug transporters are critical in drug absorption, distribution, and excretion processes. They should be included in physiological-based pharmacokinetic (PBPK) models, which help predict human drug disposition. However, predicting this is challenging during drug development, especially when liver transport is involved. However, with a realistic representation of body transport processes, an accurate model may be possible.
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Related Experiment Video

Updated: Mar 22, 2026

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Modeling drug passage into human milk.

P O Anderson1, J B Sauberan2

  • 1Health Sciences Clinical Professor, University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, California, USA.

Clinical Pharmacology and Therapeutics
|April 10, 2016
PubMed
Summary
This summary is machine-generated.

Measuring drug levels in breast milk is crucial for infant safety. This review covers methods to assess and predict medication transfer during breastfeeding, ensuring better health outcomes.

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Area of Science:

  • Pharmacology
  • Neonatal Health
  • Maternal Health

Background:

  • Breastfeeding offers significant health benefits to infants and mothers.
  • Existing resources for drug safety during lactation, like LactMed, can be incomplete.
  • Assessing drug safety in breast milk is vital, yet data is often limited.

Purpose of the Study:

  • To review methodologies for measuring drug concentrations in human breast milk.
  • To explore predictive models for drug passage into breast milk.
  • To enhance the understanding of medication safety during lactation.

Main Methods:

  • Review of existing literature on analytical techniques for quantifying drugs in breast milk.
  • Discussion of pharmacokinetic principles governing drug transfer from maternal circulation to milk.
  • Exploration of in silico and in vitro models for predicting milk-drug concentrations.

Main Results:

  • Direct measurement of drug concentrations in breast milk is feasible with various analytical methods.
  • Pharmacokinetic parameters can predict the extent of drug transfer.
  • Limited subject studies can yield significant data on drug safety in breast milk.

Conclusions:

  • Accurate measurement and prediction of drug passage into breast milk are essential for ensuring infant safety.
  • Further research into standardized methodologies and predictive modeling is warranted.
  • This review provides a foundation for evidence-based recommendations on medication use during breastfeeding.