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Updated: Jul 12, 2026

Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
Published on: January 31, 2022
Drug hepatotoxicity from a regulatory perspective
1Center for Drug Evaluation and Research, Food and Drug Administration, Federal Research Center at White Oak, Building 22:3482, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA. john.senior@fda.hhs.gov
The Food and Drug Administration (FDA) highlights challenges in identifying drug-induced liver injury (DILI) during clinical trials. Addressing these issues is crucial for patient safety and advancing liver disease research.
Area of Science:
- Hepatology
- Clinical Pharmacology
- Drug Safety
Background:
- Drug-induced liver injury (DILI) poses significant challenges in clinical practice and drug development.
- The Food and Drug Administration (FDA) plays a critical role in overseeing drug safety and efficacy.
Purpose of the Study:
- To summarize current problems in the detection, confirmation, and management of DILI from the FDA's perspective.
- To encourage research and collaboration in addressing DILI challenges.
Main Methods:
- Review of FDA's perspective on DILI issues.
- Discussion of challenges in controlled clinical trials for DILI detection and diagnosis.
Main Results:
- Identified key problems in DILI detection, confirmation, differential diagnosis, and follow-up within clinical trials.
- Highlighted the need for improved methodologies and research in DILI.
Conclusions:
- Current approaches to DILI in clinical trials have limitations.
- Further research and collaborative efforts are needed to improve DILI management and patient outcomes.
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