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Assignment 6
Explore the Drug Approval Process

In this assignment, you will select a drug that has been approved for sale in the United States and investigate how it was tested, its efficacy, and its side effects. To do so, you will practice locating and interpreting information found on a drug’s package insert.

Select a drug that has been approved for sale in the United States, and answer the following questions.

1. Enter the name of the drug you have selected here:

2. For what indications was your drug approved? When were they approved?

Instructions:

Most drugs have their own website. Find the package insert or the label on the website. Look for the words “Prescribing Information.” This insert will have a good deal of information about approved indications (in “Indications and Usage”), the efficacy results (in “Clinical Studies”), and side effects (in “Warnings” and “Adverse Reactions”) of the Phase 3 randomized controlled trials.

To find the approval dates for each indication of your drug, go to the Drugs@FDA website. After typing in your drug’s name, go to the “Approval History” link. Look for “Original Approvals or Tentative Approvals”; this is when your drug was first approved for sale. The next (longer) table describes revisions to the approval. Many revisions will involve changes to the drug label, but this table will also reveal whether the drug has obtained approval for other indications beyond the one in its initial approval. The “New Indication” or “Modified Indication” entries will contain the approval dates of any other indications, where relevant. You should be able to find an approval date for each relevant indication from the label/package insert, although this will be easier for small molecule drugs than for biologics.

Once you have identified the indications and their approval dates, fill out the following table. Add rows if necessary.

Indication

Date Approved

3. How was the drug tested during Phase 3?

Instructions:

Select one indication that you identified in question 1. The “Clinical Studies” section of your package insert/label should describe how the clinical trial(s) for that indication were run.

Once you have located the relevant clinical trial information, fill out the following table for each trial. If necessary, duplicate the table for each additional trial.

Clinical Trial

How many patients were included

(if available)?

What types of patients were included?

(e.g., “Had a heart attack in the prior two weeks”)

What drugs were in the treatment/ experimental arm of the trial?

What drugs were in the control arm of the trial?

How long were the patients followed?

3. Describe the drug’s efficacy and side effects.

Instructions:

Select one indication that you identified in question 1. Using the information found on the package insert for that indication, answer the following questions.

What health endpoints were measured?

Relative to the control drug, how much better did your drug perform?

Relative to the control drug, were your drug’s side effects better or worse?

To submit this assignment, please refer to the instructions in the course.

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