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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)
Bacillus anthracis infections,treating,20,21
20 21
Bacillus Calmette-Guerin (BCG),593
593
Bevacizumab,54,775
54 775
Biological license application (BLA),802,803,811,812
802 803 811 812
Biomarker validation from FDA submissions for in vitro diagnostics tests,413,417
413 417
distinctions between submission for medical devices,416,417
416 417
validation of genomic DNA diagnostic reagent in a 510(k) submission,413,414
413 414
validation PCR reaction diagnostic test in a 519(k) submission,414,415
414 415
in a PMA submission,415,416
415 416
Biomarkers breast cancer,382,390
382 390
colorectal cancer,388,389
388 389
DNA microarray colon cancer,392,393
392 393
hepatocellular carcinoma,393
393
exploratory biomarkers,400
400
measurement relative to chemotherapy,374
374