生物相似性FDA的观点

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生物相似性FDA的观点 1558条(本栏目收费,不能显示细节,电话13136136841)

Ion exchange (IE),171 171

Ion-exchange chromatography(IEXC),218–219 219

Lyoprotectants,304 304

Macromolecular protein,293 293

Macugen,42 42

Manufacturing process for proposed product,81–82 82

Margin determination,321–322 322

Margins and ranges defined,352 352

Marketing Authorisation Application(MAA),36 36

Mass accuracy,217 217

authorized vs. licensed,36 36

background,29–31 31

biosimilars in use,40–46,41 41

effectiveness vs. efficacy,36 36

extrapolation,39 39

FDA stance,35 35

fingerprint-like similarity,38–39 39

future of,41,42–45 45

impurity vs. attributes,40 40

India biosimilars in,40–41 41

innovator vs. originator,35 35

interchangeable biosimilars,39 39

Japan,biosimilars in,40,44 44

aggregation,11–14 14

association,11–14 14

content,180,229 229

defined,30,31 31

expression variability,22–24 24

formulations see Formulations hormones,2–3 3

immunoblot,222 222

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