Host: The Japanese Society of Toxicology
Name : The 50th Annual Meeting of the Japanese Society of Toxicology
Date : June 19, 2023 - June 21, 2023
Safety biomarkers are important drug development tool for monitoring and predicting the safety of new drug candidate compounds in nonclinical and clinical study. Although classical kidney injury biomarkers, such as serum creatinine and BUN continue to be utilized as primary renal markers in nonclinical study, they are considered poor indicators of early renal dysfunction due to limited sensitivity. Recently, FDA Biomarker Qualification Program qualified six urine biomarkers (KIM-1, clusterin, cystatin-C, N-acetyl-beta-D-glucosaminidase (NAG), neutrophil gelatinase-associagted lipocalin (NGAL), and osteopontin) to be used in standard measures of kidney function to detect early drug-induced renal tubular toxicity in phase I clinical trials. Thus, the safety biomarkers have the promise to accelerate and improve the drug development process. The urine biomarkers can be used for safety monitoring in clinical trials when nonclinical toxicology studies with a study drug demonstrate evidence of reversible histologic renal tubule damage that is associated with an elevation in any of the six urine biomarkers. However, urinary biomarkers sometimes show unexpected variability, which can complicate our understood. In this session, we will present the case of biomarker responses of drug-induced kidney toxicity in nonclinical study.
