# Home vs. Clinic Collection of Human Milk in Evaluating the Pharmacokinetics of Four Medications

> **NIH NIH R21** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2021 · $225,191

## Abstract

PROJECT SUMMARY
Breastfeeding is the recommended primary source of nutrition for infants and has been associated with cognitive
and other health benefits for the developing child. An estimated 50-80% of women take prescription medications
while breastfeeding, yet only 2% of medications have adequate data for evaluating their safety when used in
lactation. This represents a critical gap in knowledge resulting in many women either avoiding necessary
medications or discontinuing breastfeeding. The primary barrier to determining the extent of drug passage into
breast milk is collecting enough breast milk and blood samples to both quantify drug concentrations and account
for inter-individual variability in drug exposure. For numerous reasons, it is often difficult for new mothers to come
to study visits. In order to generate much-needed data on drug passage into breast milk, additional methods of
sample collection are needed that will enable more lactating women to participate and to generate a sufficient
critical mass of data to make strong recommendations on the safety of a given drug while breastfeeding.
This proposal will rigorously test the central hypothesis that home collection of human milk and blood samples
will be successfully validated against more traditional clinic-based collection methods for pharmacokinetic (PK)
studies. Building on the infrastructure of the existing UC San Diego Human Milk Research Biorepository study
and a highly qualified, multidisciplinary research team at UC San Diego and the University of Utah, we will enroll
20 breastfeeding women already prescribed either prednisone, oxycodone, sertraline, or methylphenidate, for a
total of 80 women. In each medication group, 10 women will be randomly assigned to one of two cohorts. Women
in Cohort 1 will present to clinic and provide a breast milk and blood sample that will be split into two aliquots.
Aliquot 1 will be processed and stored under rigorous study collection conditions. Aliquot 2 will be processed
and stored under mimicked home collection conditions. Storing the same sample under different conditions will
allow comparison of home collection to the gold standard of clinic collection. The data collected from Cohort 1
will be combined with existing PK data from a collaborating network to build population PK models. These PK
models will be used to generate model-predicted concentrations that will be compared with home-collected
concentrations from Cohort 2. Women in Cohort 2 will be provided instructions and supplies for home collection
of breast milk and dried blood spot samples that will be shipped to UC San Diego. Concentrations from home-
collected samples will be compared to model-predicted concentrations from the PK models generated above.
By successfully validating methods for home collections, the proposed research will transform the study of drug
passage into breast milk by dramatically expanding the number of women who can participate, ultimately leading
to a...

## Key facts

- **NIH application ID:** 10148946
- **Project number:** 1R21HD104412-01
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** CHRISTINA CHAMBERS
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $225,191
- **Award type:** 1
- **Project period:** 2020-11-15 → 2022-10-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10148946

## Citation

> US National Institutes of Health, RePORTER application 10148946, Home vs. Clinic Collection of Human Milk in Evaluating the Pharmacokinetics of Four Medications (1R21HD104412-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10148946. Licensed CC0.

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