Pharmacogenomic data submissions to the FDA: clinical pharmacology case studies

Author:

Ruaño Gualberto1,Collins Jerry M2,Dorner Andrew J3,Wang Sue-Jane4,Guerciolini Roberto5,Huang Shiew-Mei6

Affiliation:

1. Genomas LLC, New Haven, CT, USA, Department of Biochemistry and Molecular Biology, George Washington University, Washington DC, USA

2. Laboratory of Clinical Pharmacology, CDER, FDA, USA

3. Molecular Medicine, Wyeth Research

4. FDA, Inter-Center Pharmacogenomics/ Pharmacogenetics Initiative, USA

5. Millennium Pharmaceuticals, Inc., USA

6. Office of Clinical Pharmacology and Biopharmaceutics, HFD-850, Center for Drug Evaluation and Research, FDA, 5600 Fishers Lane, PKLN 6A/19, Rockville, MD 20850, USA. huangs@cder.fda.gov

Publisher

Future Medicine Ltd

Subject

Pharmacology,Genetics,Molecular Medicine

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