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WHITE PAPER: Accessing special populations: Considerations for lactation studies during drug development

The limited participation of lactating mothers in clinical trials has created a significant knowledge gap regarding the safety and impact of maternal medication use during breastfeeding. This has resulted in an absence of direct data which complicates decision-making for healthcare providers and mothers, potentially affecting the health outcomes for both mother and child.

Advancing clinical trials to include lactating mothers could provide essential data on the pharmacokinetics and safety profiles of medications during breastfeeding.

Dive into this white paper to discover:

  • The importance of conducting lactation studies during drug development programs for comprehensive drug impact understanding.
  • The role of regulatory bodies in promoting the inclusion of lactating mothers in clinical studies.
  • Unique barriers to participation faced by lactating mothers including managing feeding schedules and sleep cycles.
  • Strategies for boosting lactating mothers’ participation in clinical trials.

 

>> Read the white paper

Accessing special populations: Considerations for lactation studies during drug development