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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
218 219
Macromolecular protein,293
293
Manufacturing process for proposed product,81–82
81 82
Margin determination,321–322
321 322
Margins and ranges defined,352
352
Marketing Authorisation Application(MAA),36
36
authorized vs. licensed,36
36
biosimilars in use,40–46,41
40 46 41
effectiveness vs. efficacy,36
36
fingerprint-like similarity,38–39
38 39
impurity vs. attributes,40
40
India biosimilars in,40–41
40 41
innovator vs. originator,35
35
interchangeable biosimilars,39
39
Japan,biosimilars in,40,44
40 44
expression variability,22–24
22 24
formulations see Formulations hormones,2–3
2 3