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The New Medicines: How Drugs Are Created, Approved, Marketed, and Sold [Hardcover]

Bernice Schacter

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Table of Contents

List of Illustrations Preface Abbreviations and Acronyms The Path from Bench to Bedside How did the FDA get to be in charge? The History of Human Drugs The Eureka Moment: How New Medicines Are Discovered Test Tube Results Are Not Enough - Animal Tests for a Drug's Utility The Business Decisions - Committing to Development Production of the New Drug Laboratory and Animal Safety Testing Getting Set for Clinical Trials Phase 1 Clinical Trials Phase 2 Clinical Testing Phase 3 Testing Putting Together the Application for Approval: The New Drug Application (NDA) Now Everybody Holds Their Breath (and some people may brush up on the rules for insider trading) - Will the FDA File the NDA? The FDA Review What do outside experts think? The Advisory Committee Meeting and FDA Approval The Launch: Marketing the Drug It's Not Over Till It's Over: Post Approval Studies Are we well served?

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