doi: 10.1016/j.it.2021.10.010 133 AndrianovaIAPonomarevaAAMordakhanovaERLe MinhGDaminovaAGNevzorovaTAet al
Regulatory Expectations and Guidance Frameworks Regulatory frameworks, including the FDA 2024 guidance on oligonucleotide therapeutics and EMA guidelines concerning therapeutic proteins, require comprehensive immunogenicity risk assessments that address product quality attributes, clinical pharmacology, and impurity qualification
Bartha R, Drost DJ, Menon RS, Williamson PC
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N., McCabe, S
While the stakeholders underscore the importance of transparent, relatable policies, the emphasis on consensus can paradoxically fuel polarization as the voices that feel left on the other side of environmental justice are picked up and mobilized by populist movements