The FDA provides guidance on bioanalytical method development for industry.

Examples of Breastmilk Validation Assays and PK studies from TB clinical trials:

• Rifapentine (https://www.sciencedirect.com/science/article/pii/S0731708522001959)
• Levofloxacin
• Bedaquiline
• Delamanid (https://doi.org/10.1016/j.jpba.2024.​​116225)

Several registries, databases, and biobanks exist that can be leveraged by investigators looking to harvest data on medicines used in pregnant and lactating women.

• FDA Adverse Event Reporting System – post-marketing surveillance data including exposure and adverse drug events during pregnancy and lactation. 
• All of Us Research Program – NIH initiative that integrates survey, EHR, and biospecimen data, including for pregnant and lactating women. 
• NICHD Data and Specimen Hub – repository of deidentified biospecimens and clinical data
• PKRxiv – open-access platform hosted by University of Liverpool for sharing individual-level pharmacokinetic and pregnancy-related data.
• Pregnancy Risk Assessment Monitoring System – survey of maternal experiences and behaviour in the peripartum period.