Drug induced renal injury (DIRI) biomarkers.

Drug-induced renal injury (DIRI) remains a substantial issue in clinical practice, contributing to high morbidity, mortality, socioeconomic and healthcare cost. Traditional markers, such as serum creatinine or blood urea nitrogen, have low specificity and sensitivity for early identification, underscoring the need for new reliable biomarkers. This chapter investigates biomarker improvements for DIRI, focusing on clinical uses, limitations, and future possibilities. The chapter examines biomarkers such as neutrophil gelatinase-associated lipocalin, kidney injury molecule-1, cystatin C, β2-microglobulin and clusterin for diagnosing nephrotoxicity. In addition, we highlight the role of proteomics and metabolomics in facilitating the identification and development of novel biomarker candidates via high-throughput ultra-sensitive technology in investigating DIRI mechanisms. The chapter discusses validation frameworks, regulatory criteria for biomarker adoption in clinical settings, and how they are integrated into treatment monitoring and personalized medicine. Case examples demonstrate the real-world applicability in early diagnosis, risk classification, and therapy optimization. Standardization, cost, and translational gaps are discussed, as well as the potential for artificial intelligence and machine learning to improve biomarker processing and interpretation. Finally, this chapter emphasizes the transformative potential of DIRI biomarkers in providing a pathway to more accurate and timely identification of renal injury, improved patient outcomes, and reduced healthcare costs. Future research and global collaboration are required to fully realize the potential of these advances in clinical and regulatory settings.