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NIH Clinical Pharmacology 3-25-10Disclosure InformationChris H. Takimoto, MD, PhD• Employment: Janssen R&D/Johnson & Johnson• Stock: Johnson & Johnson• Off Label Use: I will not discuss off label use of anyproducts2
NIH Clinical Pharmacology 3-25-10Lecture Outline• Nonclinical Drug Development Definitions & Scope• Components of Nonclinical Drug Development– Pharmacology Studies– Safety Pharmacology– PK/ADME Studies– Toxicology– Starting Dose Selection and Study Desgin Issues for FIH• Nonclinical Translational Research Strategies– Targeted therapies/Biomarkers– Pharmacological Audit Trail/Model-based drug development– Translational clinical development plans3
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