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The FDAs 2022 guidance emphasizes rigorous immunotoxicity screening and organ-specific biodistribution studies, while the EMA mandates comparative benefit-risk analyses for nanosimilars [296]

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Globally, incident cases and DALYs of CKD was 18.99 million and 41.54 million in 2019, respectively (133), imposing a significant societal and individual burden

[DOI] [PubMed] [Google Scholar] 7.Hagen TM

Jaul E, Barron J (2017) Age-related diseases and clinical and public health implications for the 85 years old and over population