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Physiologically based pharmacokinetic models in developmental toxicology

E J O'Flaherty1

  • 1Department of Environmental Health, University of Cincinnati Medical Center, Ohio 45267-0056.

Risk Analysis : an Official Publication of the Society for Risk Analysis
|August 1, 1994
PubMed
Summary

Pregnancy significantly alters drug and chemical disposition due to rapid physiological changes. Physiologically-based models can account for these dynamic shifts to predict fetal exposure.

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Area of Science:

  • Pharmacokinetics
  • Physiology
  • Toxicology

Background:

  • Pregnancy involves substantial anatomic and physiologic alterations impacting drug and chemical disposition.
  • Changes in maternal systems like intestinal motility, respiration, cardiac output, and renal function are critical.
  • Maternal tissue/fluid volumes and fetal development also influence pharmacokinetics.

Purpose of the Study:

  • To review and outline physiologically-based models of pregnancy.
  • To demonstrate the utility of these models in predicting chemical exposure during gestation.
  • To provide an example of model application for fetal dose estimation.

Main Methods:

  • Development and application of physiologically-based pharmacokinetic (PBPK) models.
  • Incorporation of temporal changes in maternal physiology during pregnancy.

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  • Utilizing models to simulate chemical disposition and predict fetal exposure levels.

    • Main Results:

    • Physiologically-based models can effectively integrate dynamic pregnancy-related changes.
    • These models offer a framework for understanding altered chemical kinetics during gestation.
    • An example demonstrates successful prediction of fetal dose in animal models.

    Conclusions:

    • Physiologically-based models are essential tools for assessing chemical safety during pregnancy.
    • Understanding pharmacokinetic changes is crucial for accurate risk assessment in pregnant individuals and fetuses.
    • Model-driven predictions aid in evaluating potential developmental toxicity.