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In those materials, the Agency highlighted recurring issues: limited or inadequate safety data, concerns about characterization and impurities, lack of evidence of historical use in compounding, and potential immunogenicity risks

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"Designing Formulation Strategies for Enhanced Stability of Therapeutic Peptides in Aqueous Solutions: A Review." Pharmaceutics , 2023

Findings include: Accelerated wound closure rates in multiple animal models across all regenerative components KPV-mediated inflammation control: Reduced inflammatory cell infiltration (leukocytes, mast cells) Enhanced re-epithelialization and granulation tissue formation Improved collagen deposition and organization in healing wounds Smaller scar formation demonstrated in KPV studies, complementing tissue repair components Antimicrobial effects from KPV against S