Impact of microarray data quality on genomic data submissions to the FDA

Nature Biotechnology

Volumn 24, Issue 9, 2006, Pages 1105-1107

  Frueh, Felix W ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DECISION MAKING; DNA MICROARRAY; FOOD AND DRUG ADMINISTRATION; GENOMICS; INFORMATION PROCESSING; NOTE; PRIORITY JOURNAL; QUALITY CONTROL; DATA ANALYSIS; GENE EXPRESSION PROFILING; HUMAN GENOME; MICROARRAY ANALYSIS; PRACTICE GUIDELINE; SINGLE NUCLEOTIDE POLYMORPHISM;

DATABASES, GENETIC; GENOMICS; GOVERNMENT REGULATION; GUIDELINES; GUIDELINES AS TOPIC; INFORMATION STORAGE AND RETRIEVAL; OLIGONUCLEOTIDE ARRAY SEQUENCE ANALYSIS; QUALITY ASSURANCE, HEALTH CARE; REFERENCE STANDARDS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33748481775     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt0906-1105     Document Type: Note

References (7)

1. International Human Genome Sequencing Consortium. Nature 409, 860-921 (2001).
2. Venter, J.C. et al. Science 291, 1304-1351 (2001).
3. Lesko, L.J. & Woodcock, J. Pharmacogenomics J. 2, 20-24 (2002).
4. http://www.fda.gov/cder/guidance/6400fnl.pdf
5. http://www.cfsan.fda.gov/~dms/opa-pt58.html
6. Shi, L. et al. Expert Rev. Mol. Diagn. 4, 761-777 (2004).
7. Shi, L. et al. BMC Bioinformatics 6 suppl. Suppl. 2, S12 (2005).