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临床试验药物安全性 1506条(本栏目收费,不能显示细节,电话13136136841)
and FDA’s Guidance for Industry,706,707
706 707
and package insert,706,707
706 707
process for clinical trials on,194,195
194 195
Antibody-dependent cell cytotoxicity(ADCC),584,599,601
584 599 601
Antigen-presenting cell (APC),582
582
Anti-PD-1 antibody,281
281
Approval letter,812,814
812 814
FDA feedback at time of issue of,814,820
814 820
exemplified by multiple sclerosis,816,818
816 818
drug accountability failure of,768,769
768 769
record keeping failure of,767,768
767 768
prognostic biomarker validation,310,311
310 311
study design inclusion,380
380
surrogates criteria,380,382
380 382
thymidine phosphorylase as survival biomarker,299,300
299 300
analytical validity,412
412
biologic validity,412
412
clinical validity,412
412
Biostatistics binary variables,237,239,241,243
237 239 241 243
changes in sample size assumptions can yield dramatic changes to sample size,234,235
234 235
thymidine phosphorylase as survival biomarker,299
299
Carboplatin Maemondo study,276,278
276 278