The Case for Simulating Pregnancy

Pregnant women have long been excluded from clinical drug trials, and that gap has real consequences. When there is little to no data on how a medication behaves during pregnancy, doctors are left guessing on dosage, and patients may be undertreated, overtreated, or left without any treatment at all. Pregnancy changes the body in ways that can significantly alter how drugs are absorbed, distributed, and broken down, meaning standard doses may not work the same way.

This interview with Karen Yeo, a senior leader in physiologically-based pharmacokinetic modeling at Certara, explores how computer-based simulations are helping to address this long-standing problem. Rather than waiting for clinical trial data that may never be collected, researchers can use mathematical models of human physiology to simulate how a drug might behave in a pregnant body, and use that information to guide dosing decisions and design better studies.

Yeo also discusses the broader global health stakes: in many parts of the world, pregnant women living with conditions like malaria, HIV, or tuberculosis lack access to evidence-based treatment guidance. Better modeling, she argues, isn’t just a technical advance, it’s a matter of health equity.