Medicines in pregnancy: A clinical pharmacology extrapolation framework to address knowledge gaps.

The article discusses the challenges of using medicines during pregnancy due to limited clinical data and the need for a clinical pharmacology extrapolation framework to support pregnancy drug development strategies. It highlights the regulatory landscape, the impact of pregnancy-related physiological changes on drug exposure, and the importance of including pregnant women in clinical trials. The article emphasizes the need for an extrapolation approach to generate data in pregnancy, focusing on mother and fetal safety management, study design, and labeling updates. Additionally, it suggests using model-informed drug development (MIDD) approaches, such as physiologically-based pharmacokinetic (PBPK) modeling, to predict drug exposure and inform dosing decisions during pregnancy. [Extracted from the article]