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Instead of classifying nanomedicines as a distinct category, regulatory bodies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) emphasize a risk-based product-specific evaluation framework that calls for thorough physicochemical characterization, manufacturing reproducibility, biodistribution profiling, and safety assessment for drug products that contain nanomaterials

[DOI] [PMC free article] [PubMed] [Google Scholar] 161.Shenoy N., Creagan E., Witzig T., Levine M

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281, 1036510373 10.1074/jbc.M513094200 [DOI] [PubMed] [Google Scholar] 25.Otreba M., Rok J., Buszman E

A maintenance dose is the dose given regularly over the long term to maintain the desired effect after the initial response has been achieved