Pharmacogenomics in Drug Development and Regulatory Decision-making: the Genomic Data Submission (GDS) Proposal
Author:
Affiliation:
1. Director, Worldwide Regulatory Affairs, Wyeth Research, Collegeville, PA 19426, USA.
2. Director, Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA, Maryland, USA
Publisher
Future Medicine Ltd
Subject
Pharmacology,Genetics,Molecular Medicine
Link
https://www.futuremedicine.com/doi/pdf/10.2217/14622416.5.1.25
Reference2 articles.
1. Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Decision Making: Report of the First FDA-PWG-PhRMA-DruSafe Workshop
2. A vision for the future of genomics research
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