AGI specializes in organ-targeted toxicity assessments that provide detailed insights into tissue-specific safety liabilities that can determine the success or failure of a development program. Our studies integrate advanced imaging, histopathology, biomarker profiling, and clinical chemistry to map toxicities across critical organ systems, including cardiovascular, hepatic, renal, pulmonary, and neurological tissues. This multi-layered approach enables early detection of adverse events, precise characterization of dose-limiting toxicities, and robust evaluation of reversibility or progression over time. By modeling toxicities under clinically relevant conditions, we generate data that directly informs risk-benefit assessments and regulatory submissions, allowing sponsors to move forward with confidence.

 

Our teams work closely with sponsors to tailor protocols to the unique properties of each candidate therapy, ensuring alignment with FDA, EMA, and global expectations for organ-specific safety evaluation. All studies are supported by GLP-capable infrastructure, validated assays, and stringent quality assurance processes, safeguarding data integrity and reproducibility. With deep expertise in both exploratory and IND-enabling contexts, AGI provides a critical platform for derisking programs prior to first-in-human studies, protecting patient safety, and maximizing the likelihood of clinical success.