Clinical study design and modeling approaches to study secretion of drugs in human milk
Prerna Dodeja, Nupur Chaphekar, Taylor Laffey, Hamdan Albukhaytan, Steve Caritis, Imam Shaik, Raman Venkataramanan · 2026
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Description
Prerna Dodeja and colleagues review, in 2026, how to study drug transfer into human breast milk. Most medicines pass into milk by simple diffusion, but data are scarce. Stopping breastfeeding is rarely the right answer, they argue. Enrolling nursing mothers in studies purely to measure transfer is hard.
The review summarises measures used to quantify drug levels in milk. It lays out clinical study designs suited to lactation. Where human data are missing, laboratory, animal, and computer models can help. Formula-based estimates of milk-to-plasma ratios are explained. Pharmacokinetic models that predict drug levels over time also feature. The goal is better safety guidance for the many mothers who need medication while nursing.
Catalog record
| CREATOR | Prerna Dodeja, Nupur Chaphekar, Taylor Laffey, Hamdan Albukhaytan, Steve Caritis, Imam Shaik, Raman Venkataramanan |
|---|---|
| YEAR | 2026 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 99038 |
| LICENSE | https://creativecommons.org/licenses/by/4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |