Freshman Organic Chemistry (CHEM 125) The chemical mode of action of omeprazole is expected to be insensitive to its stereochemistry, making clinical trials of the proposed virtues of a chiral switch crucial. Design of the clinical trials is discussed in the context of marketing. Otolaryngologist Dr. Dianne Duffey provides a clinician’s perspective on the testing and marketing of pharmaceuticals, on the FDA approval process, on clinical trial system, on off-label uses, and on individual and institutional responsibility for evaluating pharmaceuticals. 00:00 – Chapter 1. Introduction: The Chemical Properties and Reactivity of Prilosec 06:58 – Chapter 2. The Economics of Clinical Trials 19:57 – Chapter 3. Duffey: How Do I Know that the Drug is Effective? 30:26 – Chapter 4. The Phases of Clinical Trials, Results for Esomeprazole and Omeprazole, and Off-Label Use 42:01 – Chapter 5. Pharmaceutical Marketing Mentality and Q&A Complete course materials are available at the Open Yale Courses website: open.yale.edu This course was recorded in Fall 2008.
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