Pharmacogenomic data submissions to the FDA: clinical pharmacology case studies.
Ruaño
Gualberto
G
Genomas LLC, New Haven, CT, USA.
Collins
Jerry M
JM
Dorner
Andrew J
AJ
Wang
Sue-Jane
SJ
Guerciolini
Roberto
R
Huang
Shiew-Mei
SM
D000818:Animals; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods*; D006801:Humans; D010597:Pharmacogenetics / Q000331:legislation & jurisprudence / Q000379:methods*; D010601:Pharmacology, Clinical / Q000331:legislation & jurisprudence / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence