Purpose Breastfeeding plays an important role in supporting infant nutrition and health, but lack of adequate safety data on medication use during lactation poses significant challenges. The objective of this study was to assess the comparability of using breast milk and blood samples collected under mimicked home conditions versus standard clinic‐based methods. Methods Paired blood and breast milk samples were obtained from lactating participants prescribed a study drug per standard of care. Correlation analysis was performed to determine the association between drug concentrations in paired samples collected under clinic and home conditions. Results Samples were collected from 27 mothers. A total of 7, 10, and 10 participants were exposed to nifedipine, escitalopram, and sertraline, respectively. Paired dried blood spot (DBS) and paired plasma to DBS samples exhibited good correlation between clinic and home conditions. Breast milk samples demonstrated good correlation for escitalopram and sertraline. Conclusions Validation of samples collected under home conditions provides an alternative method to increase enrollment and human data in lactating populations. Blood showed good correlation across all study drugs and breast milk showed good correlation for stable drugs across clinic and home condition samples. This study supports home collection of blood and breast milk samples for convenient research and clinical use.
Job et al. (Thu,) studied this question.