Clinical lactation studies. Acting on key recommendations over the last decade

Area of Science:

• Pharmacokinetics and Drug Metabolism
• Clinical Pharmacology
• Pediatric Drug Safety

Background:

• Lactating women are an understudied population in clinical trials.
• Limited drug exposure and safety data exist for this demographic.
• Accurate data is needed for safe and effective drug prescribing.

Purpose of the Study:

• To highlight the importance of including lactating women in clinical trials.
• To discuss advancements in conducting clinical lactation studies.
• To present methods for assessing infant drug exposure.

Main Methods:

• Review of recent changes in regulatory guidance and perspectives.
• Discussion of international networks promoting lactation studies.
• Application of modeling and simulation techniques.

Main Results:

• Pragmatic approaches for advancing clinical lactation studies have emerged.
• Modeling and simulation can effectively complement clinical data.
• Enhanced knowledge of infant drug exposure is achievable.

Conclusions:

• Including lactating women in trials is essential for drug safety.
• Improved methodologies facilitate robust clinical lactation studies.
• Modeling and simulation offer valuable insights into infant drug exposure.