Clinical Cancer Research - Syracuse University.ppt
Clinical Cancer Research Theresa Higgins Cancer Center Beth Israel Deaconess Medical Center Boston, MA Drugs through Pipeline (From Birth to Market) How long does it take a drug to get to market? Timeline for Drug Development Preclinical Research At Least 5 Years File “Investigational New Drug” Application with FDA Clinical Studies 7 Years Phase I Years Phase II 2 Years Phase III Years File “New Drug Application” with FDA Review by FDA PostmarketingSurveillance Approval Years Ongoing Preclinical Research At Least 5 Years Discovery and early screening pound Large-scale synthesis Animal Testing File Investigational New Drug (IND) Application with FDA Investigational New Drug A new drug, antibiotic drug, or biological drug that is used in a clinical investigation A biological product used in vitro (test tube or artificial environment) for diagnostic purposes Phase I: Screening for Safety 10-100 people, typically healthy Seeking to learn maximum safe dose of drug Length: yrs Cost: $10 Million Phase II: Establishing Protocol 50-500 patients with the disease being studied Define experimental conditions that will allow Phase III to give a definitive result Find the efficacy of treatment in the disease being studied. Length: 2 yrs Cost: $20 Million + Phase III: The Final Test 300-30,000 or more patients with the disease being studied Determine efficacy and tolerability relative to standard therapy. Length: years Cost: $45 Million File “New Drug Application” with FDA Application submitted by the manufacturer of a drug to the FDA for a license to market the drug for a specified indication Review By FDA Length: Years Labeling Phase IV Trials
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