At What Point in the Drug Approval Process Was It

question 10

Multiple Choice

At what point in the drug approval process was it discovered that the pain medication Vioxx® increased the risk of cardiac events?

• A) During preclinical animal studies.
• B) During Phase I studies in healthy volunteers.
• C) During Phase III studies with a large number of individuals with the symptom of interest pain).
• D) During the post-marketing period when the manufacturer was attempting to show the superiority of the drug over its competitors.

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Definitions:

Submucosa

Layer of tissue in the digestive tract lying just beneath the mucosa, containing blood vessels, nerves, and glands.

Serosa

Another term for serous membrane, the smooth tissue lining certain internal cavities of the body.

Chyme

The semi-fluid mass of partly digested food that moves from the stomach to the small intestine.

Enamel

The hard, protective outer layer of the tooth, made primarily of minerals and the hardest material in the human body.