PBPK Modeling in Pregnancy: Improving Drug Dosing Without Clinical Trials

Scientists are improving drug dosing for pregnant patients using advanced computer modeling known as physiologically based pharmacokinetic (PBPK) modeling. Because pregnant individuals are often excluded from clinical trials, there is limited direct data on how medicines behave in their bodies. This creates challenges for determining safe and effective doses.

PBPK modeling helps address this gap by simulating how drugs are absorbed, distributed, metabolized, and eliminated during pregnancy. These models incorporate known physiological changes—such as increased blood volume, altered organ function, and shifts in metabolism—to predict how drug exposure may differ from non-pregnant patients.

According to expert Karen Yeo, this approach allows researchers and regulators to make more informed dosing decisions without relying solely on traditional clinical trials. It can also support labeling updates and guide safer prescribing practices.

Overall, PBPK modeling is a practical and increasingly accepted strategy to improve drug safety and efficacy in pregnancy, where ethical and logistical barriers often limit direct clinical research.