Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products скачать в хорошем качестве

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. Learn more at https://www.fda.gov/drugs/regulatory-... _______________________________ FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2020 Playlist -    • 2020 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cderbsbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367