A.±3% B.±5% C.±7% D.±10%
A.1個(gè)月加速和長(zhǎng)期留樣研究數(shù)據(jù) B.2個(gè)月加速和長(zhǎng)期留樣研究數(shù)據(jù) C.3個(gè)月加速和長(zhǎng)期留樣研究數(shù)據(jù) D.6個(gè)月加速和長(zhǎng)期留樣研究數(shù)據(jù)
A.與原研藥質(zhì)量一致 B.與原研藥臨床療效一致 C.與首仿藥質(zhì)量和療效一致 D.與原研藥質(zhì)量和療效一致