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- Title
Impact of microarray data quality on genomic data submissions to the FDA.
- Authors
Frueh, Felix W.
- Abstract
The article reports on the implications of microarray data quality on the submissions of genomic data to the U.S. Food and Drug Administration. The adoption and integration of genomic data in drug development is influenced by several factors including an understanding of the disease pathophysiology. Experts believed that microarray platforms, like the MicroArray Quality Consortium, are essential tools to make reliable data for drug development and regulatory decision making.
- Subjects
UNITED States; GENOMICS; DRUG development; DECISION making; UNITED States. Food &; Drug Administration
- Publication
Nature Biotechnology, 2006, Vol 24, Issue 9, p1105
- ISSN
1087-0156
- Publication type
Article
- DOI
10.1038/nbt0906-1105