Lactation Studies White Paper

Accessing special populations: Considerations for lactation studies during drug development

A significant percentage of postpartum women need to take at least one medication, and since many of these medications can be secreted into breast milk, it is crucial to understand if the benefits of treating the mother’s medical condition outweigh the potential risk of drug exposure to the breastfed infant.

Lactation studies, with their unique challenges, require special considerations and strategies to increase access. These efforts pave the way for safer and more informed therapeutic decisions for breastfeeding women.

What you will learn:

• The importance of conducting lactation studies during drug development programs for comprehensive drug impact understanding
• The role of regulatory bodies in fostering inclusivity
• Unique barriers to participation faced by lactating mothers
• Strategies for boosting lactating mothers’ participation in clinical trials

The PPD™ clinical research business of Thermo Fisher Scientific offers a holistic approach that spans the entire spectrum of maternal health, from pregnancy to lactation, ensuring a thorough understanding of the patient journey and enabling us to deliver impactful results.