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Dockets
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Food and Drug Administration Center for Drug Evaluation and Research Pharmaceutical
Science (ACPS)
October 18, 2006 Slides
Disclaimer Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page. Topic I: Scientific
and Clinical Evidence Related to CYP2D6 Polymorphism and Response
to Tamoxifen Therapy Update
on Previous CPSC Meeting Recommendations, Introduction to
the Meeting Topics, Lawrence Lesko, Ph.D., FDA (htm)
(ppt) Importance
of Pharmacogenetics in Oncology, Richard Pazdur, M.D., FDA
(htm) (ppt) Tamoxifen
Pharmacogenetics: An FDA Perspective, Atiqur Rahman, Ph.D.,
FDA (htm) (ppt) Tamoxifen,
Endoxifen and CYP2D6 Polymorphism, Sally Yasuda, Pharm.D,
FDA (htm) (ppt) Tamoxifen
Pharmacogenetics and Prediction of Breast Cancer Relapse After
Administration of Tamoxifen, Matthew Goetz, M.D., Assistant
Professor in Oncology, College of Medicine, Mayo Clinic (htm)
(ppt) Open Public Hearing DNAdirect,
Ryan Phelan. (htm)
(ppt) Implications
of a CYP2D6 test for Tamoxifen, David A Flockhart, M.D, Ph.D.,
Indiana University School of Medicine., (Statement (htm)) (htm) (ppt) Topic II: Evaluation of transporter-based drug interactions Key
issues in the Evaluation of Drug Interactions, Shiew-Mei Huang,
Ph.D., FDA (htm) (ppt) Boehringer
Ingelheim experience/Opinion:
Transporter-based Drug Interactions, Mitch Taub, Ph.D.,
Boehringer Ingelheim Pharmaceuticals (htm)
(ppt) Clinical
Significant Transporter-based Interactions, David Greenblatt,
M.D., Clinical Significant
Interactions of OATP1B1 and Their Transporter-base Interactions,
Kathleen Giacomini, Ph.D., University of California, San Francisco
(htm) (ppt) Page last updated
November 3, 2006
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