FDAArthritisAdvisoryCommitteeMarch5,2003课件.ppt

FDA Arthritis Advisory CommitteeMarch 5, 2003 ARAVA? (Leflunomide) Aventis Pharmaceuticals Leflunomide – Presentation Agenda Introduction Michael Rozycki, PhD US Regulatory Affairs Aventis Pharmaceuticals Patient-Reported Outcomes Joseph Doyle, RPh, MBA Physical Function: Efficacy Data Karen Simpson, MD Conclusions Michael Rozycki, PhD Improvement in Physical Function Does the term “physical function” or “disability” better capture clinically relevant information ascertained in the HAQ? Are more recent derivatives appropriate and validated endpoints / substitutes? What duration of superior