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NIH Clinical Pharmacology 3-25-10Starting Dose for First in HumanStudies in Oncology• Goal:– Select a start dose that is expected to havepharmacological effects and is reasonably safe touse• Based on all available non<strong>clinical</strong> data• Scale up from animal studies– For small molecules, normalize to body surfacearea– For biologicals, scale to body weight, AUC orother exposure parameters-- S9 Guidance for Industry, 201039
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