30. Esomeprazole as an Example of Drug Testing and Usage

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: http://open.yale.edu/courses

This course was recorded in Fall 2008.