Regulated Bioanalysis of Large Molecules Bioanalysis 2020











>> YOUR LINK HERE: ___ http://youtube.com/watch?v=BvTmlDQ8BMQ

Jinhui Zhang, CDER Office of Pharmaceutical Quality, discusses the Biologics Price Competition and Innovation Act (BPCI) Act and the transition of regulatory pathway for certain biological products, workflow for regulated bioanalysis of large molecules, special consideration for bioanalysis of large molecules in biological matrixes, and the evolution of the bioanalytical methods. • _______________________________ • 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: https://www.fda.gov/cdersbia • CDER SBIA 2020 Playlist:    • 2020 CDER Small Business and Industry...   • LinkedIn:   / cder-small-business-and-industry-assistance   • Training resources: https://www.fda.gov/cderbsbialearn • Twitter:   / fda_drug_info   • CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm... • Email: [email protected] • Phone: (301) 796-6707 I (866) 405-5367

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