Objective:

To discuss the role of pharmacokinetic modeling in addressing gaps in drug use during pregnancy and its implications for dosing and research.

Key Findings:

• Limited clinical data for pregnant women leads to uncertainty in treatment decisions.
• Physiological changes during pregnancy significantly affect drug metabolism and response.
• There are critical gaps in understanding drug transporters and UGT enzymes during pregnancy.
• Clear communication can enhance willingness among pregnant women to participate in clinical research.

Interpretation:

Pharmacokinetic modeling is essential for improving drug safety and efficacy in pregnant populations by filling data gaps and informing clinical decisions.

Limitations:

• Current models may not fully account for all physiological changes during pregnancy.
• Data on certain drug metabolism pathways remains insufficient.

Conclusion:

Advancing simulation approaches can significantly improve drug development and dosing for pregnant women, addressing a critical gap in clinical research.