Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products

Manivannan Ethirajan from the Office of New Drug Products (ONDP) in the Office of Pharmaceutical Quality outlines the specification considerations for peptide-related impurities in Active Pharmaceutical Ingredients (APIs) of the generic complex peptide drugs as the ICH guideline (Q3A) does not apply to these generic peptide drug substances. Discussion includes current thinking and recommendations.
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