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)
Japan biosimilars in,40 40
Japanese encephalitis vaccine,44 44
Kjeldahl analysis,229 229
Kozlowski Steven Dr.,130–131 131
Labeling for reference product,121–122 122
Landscape biosimilar products,29–46 46
Protein aggregates,293 293
Parathyroid hormone,44 44
Patient Protection and Affordable Care Act,31,88 88
Pediatric Research Equity Act(PREA),51,119–122 122
Pediatric study plan (PSP),122–123 123
Pediatric study waiver,39 39
Peginterferon alfa-2a,43 43
Peginterferon alfa-2b,42 42