Background: Clinical studies during pregnancy are rare due to ethical and practical limitations. Giving
pregnant females the same dosing regimen used in adult males or nonpregnant females is inappropriate. Pregnancy
physiologically-based pharmacokinetic modeling is a powerful tool that can be used to refine pharmacotherapy during
Objective: This work provides a review of the current status of application of physiologically based pharmacokinetic
models in developing dosing regimens in pregnant women.
Methods: A structured search was done on Scholar Google, Science Direct and PubMed. The articles searched were
those providing physiological, anatomical and biochemical data needed for pregnancy physiologically-based pharmacokinetic
models or utilizing these models to evaluate the effect of pregnancy on drugs pharmacokinetics. Key
words used for search include: PBPK and pregnancy, pharmacokinetic during pregnancy, ethics of pregnancy studies.
The found articles were evaluated in terms of main pharmacokinetic features of the drug that were affected by
pregnancy, the structure of the model, the software platform used and quality of predicted maternal and fetal exposure.
Results: Pregnancy physiologically-based pharmacokinetic models can be used to optimize effective and safe dosing
regimens needed during pregnancy. Different model structures have been successfully used for this purpose using
different modeling software.
Conclusion: More work is needed to fill the gaps in knowledge needed to more accurately and mechanistically simulate
simultaneous exposure of the pregnant mother and her fetus/ embryo to drugs using pregnancy physiologicallybased
pharmacokinetic modeling approach.