The proceedings are now available:

• Entire proceedings - (9,136 KB)
• Table of Contents
• Proceedings by section:
  • Section I: Fundamental Legal, Statistical, Industrial, and Regulatory Bases for Dose Determination
    • Interface of FDA product decisions and science, Terry Harvey
    • Clinical dose determination, Dwight Mercer
    • The impact of dose determination on development of animal drugs, Rainer Muser
    • Discussion
    • What is statistical significance in dose determination? Jean Powers
    • What is an adequate base for dose determination? Daniel Gingerich
    • Dose determination: what is substantial evidence? T. Jefferson Murphy
    • Discussion
  • Section II: Pharmacological Basis of Dose Determination of Antimicrobial Drugs
    • The value and limitation of pharmacokinetics in predicting dosage regimens
      • Richard Teske
      • Gary Koritz
      • J. Edmund Riviere
    • Comments on pharmacokinetics
      • Stephen Bai
      • Jerry Brunton
    • Some scientific bases used in extrapolation, Thomas Powers
    • Human food safety aspects of dose determination, Robert Livingston
    • Discussion
  • Section III: Experimental Design of Dose Determination Studies with Antimicrobial Drugs
    • Use of clinical trials for dose determination
      • Thomas Keefe
      • Harlan Bigbie
      • Wally Brandt
    • Comments on clinical trials
      • Donald Gable
      • Lloyd Davis
    • Discussion
    • Use of animal models for dose determination of antimicrobial drugs
      • Donald Campbell
      • Robert Furrow
      • Jerry Ling
      • George Gunderson
    • Comments on animal models
      • James Colaianne
      • William Jenkins
    • Discussion
    • The future for dose determination, Robert Baldwin
  • Task Force Report and Recommendations