Drug candidates can induce hepatic steatosis, which is characterized by the accumulation of lipids in liver cells without any other morphological changes. Clinical studies have reported two types of fat deposition patterns: diffuse and non-diffuse. The diffuse pattern is more common, while the non-diffuse pattern includes several subtypes such as geographic, focal, sub-capsular, multifocal, and perivascular patterns. Since drug-induced hepatic steatosis can have limited safety margins, it is crucial to develop methods to monitor its occurrence and severity during preclinical and clinical studies. However, liver biopsy, which is considered the gold standard for diagnosing hepatic steatosis, has several limitations, such as invasiveness, risk of hemorrhage and morbidity, and sampling errors due to the heterogeneity of fat distribution in the liver. Therefore, liver biopsy is not suitable for monitoring drug-induced hepatic steatosis, and there is currently no established monitoring method for this condition.
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