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)
Office of Communication Outreach and Development (OCOD),109 109
Oligosaccharides defined,132 132
O-N-acetylgalactosamine,227 227
One-dimensional SDS-PAGE,221 221
One sample defined,348–349 349
One-size-fits-all case-by-case vs.,37 37
Orbitrap mass spectrometry use of,38–39 39
Originator innovator vs.,35 35
Orthogonal testing in statistical modeling,349 349
Oxidation,272,297–298 298
Oxidized forms target protein derivatives,236 236
tailored risk assessment tool development,251–253,252 252
threshold definition for,253–254 254
Risk assessment tools,251 251
Risk number (RN),251,254 254