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Despite promising outcomes, translational hurdles persist, including extract standardization, pharmacokinetic limitations, and regulatory barriers
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Analytical assessment procedures typically include confirmation of peptide identity, purity evaluation using validated chromatographic techniques (such as HPLC), and batch-level consistency review
The following is a summary of the comments we received and our responses Comment: Several commenters expressed concerns about the proposed inclusion of proprietary measures in ASM that are controlled by private vendors, rely on non-transparent instruments or risk adjustment methods
