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Anti-inflammatory nanoparticles significantly improve muscle function in a murine model of advanced muscular dystrophy

The FDA applied a four-part statutory test under 21 CFR 216.23(c): physical and chemical characterization, historical compounding use, evidence of effectiveness, and safety

Factors such as potency, additional ingredients, and formulation affect their efficacy

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Important upfront: in the Western pharmaceutical world BPC-157 never passed Phase 3 trials (= the large clinical trials required before drug approval)

Any temperature excursion above 8C accelerates peptide aggregation