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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