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Translational success will require (i) rigorous preclinical-to-clinical pipelines that include long-term toxicity and biodistribution studies, (ii) GMP- compliant manufacturing to ensure reproducibility and scalability, (iii) adaptive trial designs capable of evaluating patient-specific nanotherapies, and (iv) clearer regulatory alignment across FDA/EMA to classify and approve multifunctional nanoplatforms

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ACKNOWLEDGEMENTS The authors acknowledge the technical assistance provided by Ruth Pfeiffer

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