Emerging Technologies and Advanced Biomarkers for Enhanced Toxicity Prediction and Safety Pharmacology

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Background: Biomarkers are important tools in toxicology that can improve risk assessment, early detection of organ injury, and monitoring of pharmacological responses. However, rigorous validation is necessary to justify use for regulatory decisionmaking. Purpose: This article reviews the current landscape surrounding established and emerging biomarkers of toxicity across multiple techniques, with a focus on assessment of merits, limitations, and validation needs. Main Body: An overview of common clinical chemistry biomarkers used for safety monitoring of liver, kidney, heart, and inflammation is first provided, highlighting their biological relevance and applications in detecting organ dysfunction. Novel protein biomarkers emerging for enhanced sensitivity of injury detection are then discussed, such as microRNAs for liver and clusterin for kidney. Metabolomic biomarker approaches to assess biofluids and mitochondrial toxicity are outlined, along with toxicogenomic markers of susceptibility like HLA alleles. Non-invasive imaging techniques including ultrasound, MRI, and PET tracers for organ function are explored as techniques that provide additional modalities for biomarker measurement. Emerging tools like organ microphysiological systems and high-throughput omics for biomarker discovery are also described. Conclusion: While great progress has been made, translation and qualification of novel biomarkers remains challenging. This review synthesizes key developments across biomarker categories, evaluates readiness for regulatory use, and outlines strategic considerations for fit-for-purpose biomarker validation to advance integration into drug development programs.