Regulated Bioanalysis of Large Molecules - Bioanalysis 2020

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.
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