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- Title
Cancer trials get set for biomarkers.
- Authors
Bouchie, Aaron
- Abstract
Reports on the cancer trials for biomarkers. Recognition of use of biomarkers in clinical trials by the US Food and Drug Administration (FDA; Rockville, MD, USA); Need of agreement for standards for determining the validity of a biomarker before any can be used in the drug regulatory process; Announcement of a system for classifying biomarkers by the FDA; Readiness of the FDA in working with increasing number of firms generating pharmacogenomic data, based on pharmacogenomics guidance and decisions concerning molecular diagnostics.
- Subjects
UNITED States; BIOMARKERS; CLINICAL trials; DRUG delivery systems; PHARMACOGENOMICS; MOLECULAR diagnosis; MEDICAL experimentation on humans; CANCER vaccines; UNITED States. Food &; Drug Administration; MOLECULAR dynamics
- Publication
Nature Biotechnology, 2004, Vol 22, Issue 1, p6
- ISSN
1087-0156
- Publication type
Article
- DOI
10.1038/nbt0104-6