TY - CHAP M1 - Book, Section TI - Chapter 4. Regulatory Considerations in Pharmacogenomics at EMA and US FDA A1 - Paulmichl, Markus A1 - Maliepaard, Marc A1 - Papaluca, Marisa A1 - Grimstein, Christian A2 - Bertino, Joseph S. A2 - DeVane, C. Lindsay A2 - Fuhr, Uwe A2 - Kashuba, Angela D. A2 - Ma, Joseph D. PY - 2013 T2 - Pharmacogenomics: An Introduction and Clinical Perspective AB - Review and discuss the regulatory considerations for pharmacogenomics set forth by the European Medicines Agency (EMA).Review and discuss the regulatory considerations for pharmacogenomics set forth by the US Food and Drug Administration (FDA).Understand how these regulatory agencies have similarities and differences in their rules and application. SN - PB - The McGraw-Hill Companies CY - New York, NY Y2 - 2024/04/23 UR - accesspharmacy.mhmedical.com/content.aspx?aid=56875471 ER -