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Related Experiment Video

Updated: Oct 4, 2025

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Physiologically Based Pharmacokinetic Modeling in Pregnant Women Suggests Minor Decrease in Maternal Exposure to

Liang Zheng1,2, Hongyi Yang2, André Dallmann3

  • 1Department of Clinical Pharmacology, The Second Hospital of Anhui Medical University, Hefei, China.

Frontiers in Pharmacology
|February 7, 2022
PubMed
Summary

This study developed a physiologically based pharmacokinetic (PBPK) model for olanzapine in pregnancy. The model suggests minor changes in olanzapine exposure during pregnancy, indicating dose adjustments may not be necessary.

Keywords:
PBPKmetabolic enzymesolanzapinepharmacokineticspregnancy

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Area of Science:

  • Pharmacokinetics
  • Pharmacology
  • Maternal-Fetal Medicine

Background:

  • Pregnancy induces physiological changes impacting drug disposition.
  • Olanzapine is used for schizophrenia in pregnant women, but its pharmacokinetics are not well understood.

Purpose of the Study:

  • To develop and validate a physiologically based pharmacokinetic (PBPK) model for olanzapine in pregnant individuals.
  • To predict olanzapine pharmacokinetics across pregnancy trimesters.

Main Methods:

  • A PBPK model was developed and validated in non-pregnant adults.
  • Gestation-related physiological changes were incorporated to predict pharmacokinetics in pregnancy.
  • Model predictions were compared against reported time-concentration data.

Main Results:

  • The PBPK model accurately simulated olanzapine time-concentration curves.
  • Geometric mean fold errors for Cmax and AUC were 1.14 and 1.09, respectively.
  • Predicted systemic exposure changes were less than 28% for a 10 mg daily dose throughout pregnancy.

Conclusions:

  • Physiologically based pharmacokinetic modeling suggests minor olanzapine exposure changes during pregnancy.
  • Reduced CYP1A2 activity appears counteracted by increased UGT1A4 activity.
  • Dose adjustment for olanzapine is likely unnecessary in pregnant women with prior effective treatment, assuming no fetal toxicity.