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Related Experiment Video

Updated: Jun 26, 2026

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
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Validating Well-Functioning Hepatic Organoids for Toxicity Evaluation.

Seo Yoon Choi1, Tae Hee Kim1,2, Min Jeong Kim1

  • 1Division of Toxicological Research, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju 28159, Republic of Korea.

Toxics
|May 24, 2024
PubMed
Summary

Human hepatic organoids derived from stem cells show promise for drug toxicity testing. These validated models accurately distinguished between toxic and non-toxic substances, advancing drug development safety assessments.

Keywords:
3D culturealternative testliver organoidliver toxicity test

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Area of Science:

  • Biotechnology
  • Drug Development
  • Toxicology

Background:

  • Organoids are 3D organ-like tissues bridging animal and human studies in drug development.
  • Current organoid toxicity studies are limited, necessitating further research.
  • Human hepatic organoids offer a potential in vitro model for drug-induced liver injury assessment.

Purpose of the Study:

  • To analyze the functionality and gene expression of human hepatic organoids derived from induced pluripotent stem cells.
  • To utilize these organoids for toxicity assessment of known hepatotoxic and non-hepatotoxic substances.
  • To validate hepatic organoids as a reliable model for drug toxicity evaluation.

Main Methods:

  • Induced pluripotent stem cell-derived hepatic organoids were differentiated and characterized.
  • Functional assessments included glycogen storage, albumin/bile acid secretion, and cytochrome P450 (CYP) activity.
  • Toxicity evaluations were performed using ketoconazole, troglitazone, tolcapone (hepatotoxic), and sucrose, ascorbic acid, biotin (non-hepatotoxic).

Main Results:

  • Hepatic organoids demonstrated functional similarity to the human liver.
  • The organoid model successfully differentiated between hepatotoxic and non-hepatotoxic substances.
  • Toxicological changes in hepatotoxic drug-treated organoids were analyzed, confirming model efficacy.

Conclusions:

  • Functionally validated human hepatic organoids are promising models for drug toxicity evaluation.
  • These organoids can accurately assess drug-induced liver injury.
  • Hepatic organoids offer a valuable tool for advancing preclinical drug safety testing.