Pharmacogenomic data submissions to the FDA: clinical case studies.
Trepicchio
William L
WL
Clinical Research and Pharmacogenomics, Millennium Pharmaceuticals, 40 Landsdowne Street Cambridge, MA 02139, USA. wtrepicchio @mpi.com
Williams
Grant A
GA
Essayan
David
D
Hall
Sue T
ST
Harty
Lea C
LC
Shaw
Peter M
PM
Spear
Brian B
BB
Wang
Sue Jane
SJ
Watson
Mark L
ML
D016022:Case-Control Studies; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods*; D006801:Humans; D010597:Pharmacogenetics / Q000331:legislation & jurisprudence / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence