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In this study, the reaction volume was increased to 5 mL from the 100 L used in our previous study at 100 mM GSH to confirm the feasibility of large-scale production using simple 1,000-mL rection systems, for example

Much of our understanding comes from laboratory research, animal studies, and growing clinical experience

Two commenters stated that they believe treating payment for biosimilars in a manner similar to that of multiple source drugs, even in the limited circumstances described in the proposal, would distort the ASP-based payment system as a whole for biosimilars

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