Pharmacogenomic data submissions to the FDA: non-clinical case studies

Author:

Leighton John K1,DeGeorge Joseph2,Jacobson-Kram David3,MacGregor James4,Mendrick Donna5,Worobec Alexandra6

Affiliation:

1. Division of Oncology Drug Products, CDER, FDA, 5600 Fishers Lane, Rockville, MD 20850, USA. leightonj@cder.fda.gov

2. Research and Development Safety Assessment, Novartis Pharmaceuticals, USA

3. CDER, Office of New Drugs, FDA, USA

4. National Center for Toxicological Research, FDA, USA (retired)

5. Toxicogenomics, Gene-Logic, USA

6. CDER, FDA, USA

Publisher

Future Medicine Ltd

Subject

Pharmacology,Genetics,Molecular Medicine

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