Clinical Pharmacology Subcommittee Meeting

November 14-15, 2005

 

Table of Contents

  1. Tentative agenda 
  2. Draft questions 
  3. Topic 1A: Label Recommendations 
  4. Topic 1B: Polymorphism of Warfarin

Scone, Elizabeth et al., “The impact of CYP2C9 and VKORC1 genetic polymorphism and patient characteristics
upon warfarin dose requirements: proposal for a new dosing regimen”, Blood, 1 October 2005, vol 106, no. 17: 2329- 2333.

  1. Topic 1B: Model-Based Warfarin Dose

Hillman, Micheal et al., “A Prospective, randomized Pilot Trial of Model-Based Warfarin Dose Initiation using CYP2C9 Genotype and Clinical Data”, Clinical Medicine & Research, 3 August 2005, vol. 3, No. 2: 137- 145.

  1. Topic 2: Case study, A quantitative approach to assess the benefits of incorporating pharmacogenomic
    testing in a phase III clinical Study