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In conclusion, the paper provides evidence that the reduction of GLP-1+ cells is a general feature of ileal and colonic inflammation in mice and humans and is likely due to altered epithelial differentiation driven by changes in cellular metabolism, particularly mitochondrial dysfunction.

Biowaiver acceptance criteria are based on the in vitro characterization of the drug substance and drug product using the Biopharmaceutics Classification System (BCS)

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The validated method was applied to pharmacokinetic studies following intravenous (IV, 0.5 mg/kg) and subcutaneous (SC, 1 and 2 mg/kg) administration in rats