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The mechanistic data is strong

A notable exception is the recent progression into Phase I human clinical trials of novel oral lipid-based formulations (e.g., iCo-019 for the oral delivery of amphotericin B) ( 3.1 Industrial scale-up and manufacturing feasibility Although the complex surface modification strategies discussed in this paper, such as LbL self-assembly and multi-ligand targeting, have demonstrated excellent barrier-overcoming capabilities in laboratory studies, their clinical translation still faces significant industrial production challenges

In Clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List.