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Biomedical nanomaterials have ushered in a new era in healthcare by enabling revolutionary advancements in drug delivery, diagnostic imaging, regenerative medicine, and biosensing. These materials possess unique physicochemical properties such as nanoscale size, high surface area-to-volume ratios, and surface functionalization, which allow for improved therapeutic targeting and efficacy. However, these same properties raise critical concerns about their interactions with biological systems and potential adverse health effects. This paper provides a comprehensive review of the current landscape of safety and toxicological assessments of biomedical nanomaterials. It examines the underlying mechanisms of nanotoxicity, evaluates in vitro, in vivo, and computational testing methods, and explores regulatory frameworks designed to ensure safety. Furthermore, it highlights ongoing challenges such as variability in nanomaterial characterization, data gaps in long-term toxicity, and lack of standardized protocols. The paper concludes by discussing future perspectives to advance nanotoxicology research, emphasizing interdisciplinary collaboration, standardization, and the integration of novel technologies to support the safe clinical translation of nanomedicine.
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