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Regulatory Expectations for Immunogenicity Control During ANDA review of peptide drugs, regulatory agencies evaluate impurity-related immunogenic risk using a comparability-based and risk driven approach: Impurities present in the RLD at similar levels are generally acceptable

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Loren Pickart, Ph.D is being referenced as one of the leading scientists involved in the research and development of GHK-Cu

We hope these findings can be helpful for clinicians to better apply them in practice