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pre-clinical and clinical regulatory overview

Outline I. New Drug Review Process: First Principles II. FDA Model of Serial Evaluation:Investigational New Drug (IND) .... Pre-Clinical studies .... Clinical Trials Phases I ? IV New Drug Application (NDA)Post-Marketing Surveillance III. Life Science Reviewers: Roles/Opportunities Pharmacology Physiology Toxicology PathologyMolecular Biology Chemistry Statistical ScienceVeterinary Med9447

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pre-clinical and clinical regulatory overview

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    1. Pre-clinical and Clinical Regulatory Overview Albert DeFelice, Ph.D. Supervisory Pharmacologist Division of Cardio-Renal Drug Products Office of Drug Evaluation I Office of New Drugs Center for Drug Evaluation and Research Food and Drug Administration Public Health Service Department of Health and Human Services Disclaimer: Views and opinions expressed are personal, and do not necessarily reflect those of the Food and Drug Administration or the Public Health Service

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