Office of Clinical Pharmacology (OCP): Biosimilars - Bioanalysis 2020

Salaheldin S. Hamed, CDER Office of Clinical Pharmacology, provides an introduction to biosimilars to include submission components and bioanalysis. He shares recommendations and the following case examples: bioanalysis platform, validation: QC, SC, and Long-term stability, and validation: SC.
_______________________________
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 and free continuing education credits: www.fda.gov/cd...
CDER SBIA 2020 Playlist: • 2020 CDER Small Busine...
LinkedIn: / cder-small-business-an...
Training resources: www.fda.gov/cd...
Twitter: / fda_drug_info
CDER small business e-mail update subscription: updates.fda.go...
Email: [e-mail]
Phone: [phone] I [phone]