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These processes can affect formulation stability, drug release, and safety, while the resulting degradation products may also contribute to toxicity during chronic administration (Perrigue et al., 2021)

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What did the FDA actually do

4.1.4 Biodegradability and biocompatibility The choice of biomaterial is a crucial step in nanoparticle development, as the properties of biomaterials reflect not only physical characteristics but also their biodegradation and biocompatibility profiles, in which the suitable biomaterials should exhibit non-immunogenicity (Nunes et al., 2022

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