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Related Experiment Videos

Drugs in Lactation.

Philip O Anderson1

  • 1Division of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, 9500 Gilman Drive, MC 0657, La Jolla, California, 92093-0657, USA. phanderson@ucsd.edu.

Pharmaceutical Research
|February 8, 2018
PubMed
Summary

Lack of drug safety data hinders breastfeeding. New methods using computer modeling show promise for predicting drug excretion into breastmilk, improving medication use for nursing mothers.

Keywords:
breast feedingdrug excretionhuman milkmodelingpharmacokinetics

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Clinical pharmacology and therapeutics·2025

Area of Science:

  • Pharmacology
  • Lactation Science
  • Drug Development

Background:

  • Information on drug use during lactation is limited, particularly for newer medications.
  • Established principles of drug transfer into breastmilk are not always prospectively applied.
  • Preclinical rodent models for assessing drug excretion into milk are unreliable due to species-specific differences.

Purpose of the Study:

  • To address the lack of data on drug safety during breastfeeding.
  • To explore improved methods for predicting drug excretion into breastmilk.
  • To leverage new FDA labeling requirements for better drug development.

Main Methods:

  • Critique of existing preclinical models for drug excretion studies.
  • Discussion of the gold standard: measurement of drug concentrations in humans.
  • Highlighting the potential of computer modeling for predicting drug transfer.

Main Results:

  • Rodent models show significant limitations in predicting human drug excretion into breastmilk.
  • Human pharmacokinetic data remains the definitive measure of drug transfer.
  • Computer modeling offers a promising alternative to traditional animal testing.

Conclusions:

  • New FDA regulations provide an opportunity to implement computer modeling in preclinical drug development.
  • Modeling can replace unreliable animal testing for assessing drug excretion into breastmilk.
  • Improved prediction of drug transfer will enhance the safe use of medications for nursing mothers.