Food and Drug Administration

Advisory Committee for Pharmaceutical Science

Clinical Pharmacology Subcommittee

November 3, 2004

Slides

Update: Topics Previously Presented to the CPSC, Dr. Lawrence LEsko, PhD, FCP, FDA (HTM) (PPT)

Pharmacogenetics (PGx) of Irinotecan: Scientific and Clinical Impact of UGT Polymorphism: Background, Dr. Lawrence Lesko, PhD, FCP, FDA (HTM) (PPT)

Scientific and Clinical Impact of UGT1A1 Polymorphism: Evidence, Atiqur Rahman, PhD, FDA (HTM) (PPT)

Current and Future Perspectives on Irinotecan Pharmacogenomics, Drs. Luis Parodi, PhD, Dr. Mark Morrison, MD PhD & Dr. Akintunde Bello, PhD, Pfizer (HTM) (PPT)

Pharmcogenetics of Irinotecan- Clinical Perspectives: Utility of Genotyping, Dr. mark Ratain, MD, University of Chicago (HTM) (PPT)

Drug-Drug Interaction Concept Paper: Issues Related to CYP/Transporter-and Induction-Based Interactions and Multiple-Inhibitor Drug Interaction Studies: Relevant Principles of Drug Interaction Concept Paper, Dr. Shiew-Mei Huang, PhD, FDA (HTM) (PPT)

Update on Drug-DRug Interactions - A Scientific Perspective, KEith Gottesdiener, Merck Ressearch Laboratories (HTM) (PPT)

Mechanisms of Hepatic Enzyme Induction in Humans and How to Assess It In Vitro, Dr. Edward LeCluyse, PhD, CellzDirect, Inc. (HTM) (PPT)

Multiple Inhibitory Studies What, Why, and How, Dr. Kellie Reynolds, PharmD,. FDA (HTM) (PPT)

Drug-Drug Interactions In Vivo and In Vitro Studies: Focus on Transporters - Background: Focus on P-gp Other Transporters, Dr. Giacomini (HTM) (PPT)

Questions to the Committee: In Vitro and In Vivo Drug-Drug Interaction Concept Paper: Issues Related to Transporter-and Induction-Based Interactions and Multiple Inhibitor Drug Interaction Studies (HTM) (PPT)