临床试验药物安全性 1506条(本栏目收费,不能显示细节,电话15274084725)
and FDA’s Guidance for Industry,706,707 707
and package insert,706,707 707
process for clinical trials on,194,195 195
Antibody-dependent cell cytotoxicity(ADCC),584,599,601 601
Antigen-presenting cell (APC),582 582
Anti-PD-1 antibody,281 281
Approval letter,812,814 814
FDA feedback at time of issue of,814,820 820
exemplified by multiple sclerosis,816,818 818
drug accountability failure of,768,769 769
record keeping failure of,767,768 768
prognostic biomarker validation,310,311 311
study design inclusion,380 380
surrogates criteria,380,382 382
thymidine phosphorylase as survival biomarker,299,300 300
analytical validity,412 412
biologic validity,412 412
clinical validity,412 412
Biostatistics binary variables,237,239,241,243 243
changes in sample size assumptions can yield dramatic changes to sample size,234,235 235
thymidine phosphorylase as survival biomarker,299 299
Carbamazepine,517,518 518
Carboplatin Maemondo study,276,278 278