癌症临床试验(英文版）精选.pptVIP

Cancer Clinical Trials In-Depth Information The Drug Development and Approval Process 1. Early research and preclinical testing 2. IND application filed with FDA 3. Clinical trials (phases 1, 2, and 3) 4. NDA filed with FDA 5. FDA validates claim and approves drug Phases of Clinical Trials Phase 1: 15-30 people What dosage is safe? How should treatment be given? How does treatment affect the body? Phase 2: Less than 100 people Does treatment do what it is supposed to? How does treatment affect the body? Phases of Clinical Trials Phase 3: From 100 to thousands of people Compare new treatment w