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The agency says compounded drugs containing BPC-157 may pose immunogenicity risks, may involve peptide-impurity and active-ingredient characterization complexities, and have no or only limited safety information for the proposed routes of administration
Rodent protocols use 50100 higher per-kilogram doses because metabolic rate, receptor density, and clearance kinetics differ across species
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Proactive strategiessuch as rigorous in vitro cytotoxicity testing, advanced animal models, and phased clinical trialsare essential to anticipate and mitigate adverse effects
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