Role of Pharmacogenetics in Registration Processes

Author:

Kim Myong-Jin,Zineh Issam,Huang Shiew-Mei,Lesko Lawrence J.

Publisher

John Wiley & Sons, Inc.

Reference48 articles.

1. US FDA Critical Path Initiative http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/defaulthtm

2. US FDA Genomics at FDA http://www.fda.gov/drugs/scienceresearch/researchareas/pharmacogenetics/default.htm

3. Integration and use of biomarkers in drug development, regulation and clinical practice: A US regulatory perspective;Amur;Biomarkers Med.,2008

4. FDA/PhRMA/DruSafe/PWG 2002 Workshop on Pharmacogenetics/Pharmacogenomics in Drug Development and Regulatory Decision-Making 2002

5. FDA/DIA/PhRMA/PWG/Bio 2003 Workshop on Pharmacogenomics in Drug Development and Regulatory Decision-Making: The Genomic Data Submission (GDS) Proposals 2003

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