Food and Drug Administration

Advisory Committee for Pharmaceutical Science

Clinical Pharmacology Subcommittee

November 3-4, 2004

Draft Agenda (HTM) (PDF) (Word)

Draft Questions (HTM) (PDF) (Word)

Topic 1. Pharmacogenetics of Irinotecan: Scientific and Clinical Impact of UGT Polyymorphism (HTM) (PDF) (Word)

Topic 2. Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling (HTM) (PDF) (Word)

Topic 3. Innovation/Stagnation - Challenge and Opportunity on the Critical Path to New Medical Products (PDF)

Bibliography (HTM) (PDF) (Word)

Background Document on the UGT1A1 Polymorphisms and Irinotecan Toxicity, Pfizer (PDF)

Addendum to the Background Document on the UGT1A1 Polymorphisms and Irinotecan Toxicity, Pfizer (PDF)