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Food and Drug Administration

Center for Drug Evaluation and Research

Pharmaceutical Science (ACPS) 

October 18, 2006



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., Turfs University (htm) (ppt)

Clinical Significant Interactions of OATP1B1 and Their Transporter-base Interactions, Kathleen Giacomini, Ph.D., University of California, San Francisco (htm) (ppt)

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