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By focusing on mechanistic in vitro and in vivo studies, this review consolidates current preclinical findings, clarifies their experimental context, and highlights critical limitations, most notably the scarcity of mechanistic human data

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Animal Toxicology Studies Animal toxicology studies tested doses from 0.0027 mg/lb to 9.1 mg/lb via intraperitoneal, intramuscular, intravenous, and oral routes for up to 6 weeks, finding: No acute toxic or lethal dose No gross or histologic toxicity in major organs No hepatotoxicity or nephrotoxicity Negative Ames test (no mutagenicity) Negative chromosomal aberration tests (no genotoxicity) No teratogenicity in rat pregnancy studies No local injection site irritation The LD1 (minimum lethal dose) could not be achieved despite aggressive testing

Contrary, the colon-colon anastomosis and adjacent colon in animals treated with the pentadecapeptide BPC 157 sustained markedly higher infunded volume without leaking