Mahor A, Singh PP, Bharadwaj P, Sharma N, Yadav S, Rosenholm JM, Bansal KK
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Given that diarrhea and not endotoxemia is one of the principal clinical consequences of infection with enteric toxigenic bacteria, which demonstrably affect tight junction function, one must differentiate the modest increase in paracellular permeability reported in inflammatory conditions with no known over acute clinical consequences from the marked increase in paracellular permeability induced by enteric exotoxins with consequent massive fluid and electrolyte secretion and diarrhea
relative to conventional sequences, its proteolytic efficiency is increased 3.2-fold and it triggers efficient release when MMP-2 exceeds 50 nM, achieving ~60% cumulative release within 12 hsubstantially outperforming nonresponsive carriers [131, 132]
What it does is initiate a formal rulemaking process under the Federal Food, Drug, and Cosmetic Act in which the FDA must publish a proposed rule, accept public comment typically for 60 to 90 days and issue a final determination