Pharmacogenomic data submissions to the FDA: clinical case studies

摘要: William L Trepicchio†1, Grant A Williams2, David Essayan3, Sue T Hall4, Lea C Harty5, Peter M Shaw6, Brian B Spear7, Jane Wang8 & Mark Watson9 †Author for correspondence 1Director, Clinical Research and Pharmacogenomics, Millennium Pharmaceuticals, 40 Landsdowne Street Cambridge, MA 02139, USA E-mail: wtrepicchio @mpi.com 2Deputy Director, Division of Oncology Drug Products, Medical Officer, CDER, FDA, 3Director, Regulatory Affairs, Amgen, 4Director, US GlaxoSmithKline, 5Associate Pfizer, 6Director, Pharmacogenomics Human Genetics, Bristol-Myers Squibb, 7Director, Abbott Laboratories, 8Lead Senior Mathematical Statistician – FDA Inter-Center Pharmacogenomics/ Pharmacogenetics Initiative, 9Director,