Це відео не доступне.
Перепрошуємо.
Complex Peptide ANDAs: Test/Reference Comparability (11of35) Complex Generics - Sep. 25-26, 2019
Вставка
- Опубліковано 14 сер 2024
- Cameron Smith from the Office of Lifecycle Drug Products in the Office of Pharmaceutical Quality covers the regulatory pathway for synthetic generic peptides. He also discusses therapeutic equivalence, peptide characterization, peptide comparability studies, formulation changes and container closure systems.
Learn more at www.fda.gov/dr...
_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Visit www.fda.gov/cd... and www.fda.gov/cd... for news and a repository of training activities.
Email: CDERSBIA@fda.hhs.gov
Phone: (301) 796-6707 I (866) 405-5367
LinkedIn: / cder-small-business-an...
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.go...