安全有效是和风险管理.pptVIP

Clinical Efficacy Safety and Risk Management Therese M. Kitt, M.D. Senior Medical Director, Medical SciencesAstellas Pharma US, Inc. Clinical Trials with Vernakalant Injection Phase 1 Studies Single dose infusion Mass balance Phase 2 Studies Electrophysiology study CRAFT: Atrial fibrillation Phase 3 Studies ACT I: Atrial fibrillation (AF) ACT III: Atrial fibrillation or flutter (AF/AFL) ACT II: AF/AFL post CABG or valvular surgery ACT IV: AF open label Scene 2: Atrial flutter Dose Exposure Clinical Efficacy and Safety CRAFT (Dose Ranging Study)Number of Subjects in Sinus Rhythm at 60 Min