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NIH Clinical Pharmacology 3-25-10S9 Oncology Specific Guidance• Applies to targeted small molecules andbiopharmaceuticals used for treating “patients withadvanced disease and limited therapeutic options”– Advanced cancer is a progressive, fatal disease– Existing therapies have limited effectiveness– Treatment at or close to adverse effect dose levels• Type, timing, and flexibility of oncology studies maydiffer from other therapeutic areas• Does NOT apply to cancer prevention, supportivecare, healthy volunteers, radiopharmaceuticals,vaccines, cellular or gene therapies-- S9 Guidance for Industry, 20108
NIH Clinical Pharmacology 3-25-10S9 Oncology Specific GuidanceGoals of Non<strong>clinical</strong> Testing1. Identify the pharmacologic properties of apharmaceutical2. Understand the toxicological profile of apharmaceutical3. Establish a safe initial dose level of the firsthuman exposure-- S9 Guidance for Industry, 20109
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