Exam 2 PPT Slides - Supply Chain

Question 1 of 12

1

Drug: “Substances that produce a change in cellular or physiological functioning of humans.”

Select one of the following:

True
False

Explanation

Question 2 of 12

1

For Drugs... End-point of the supply chain drives demand

Select one of the following:

True
False

Explanation

Question 3 of 12

1

The five factors influencing prescribing behavior are:

Select one or more of the following:

Education
Colleagues or other health care providers
Control and regulatory mechanisms
Demands by consumers and society
Promotional activities by drug manufacturers
Kickbacks from pharmaceutical companies

Explanation

Question 4 of 12

1

What are the two main acts used by the FDA to control pharmaceuticals?

Select one or more of the following:

Food, Drug, and Cosmetic Act
Public Health Service Act
HIPPA Act
Omnibus Act

Explanation

Question 5 of 12

1

Non-FDA-approved (“off-label”) indications are uses of a product that were not approved by the FDA, but have shown value after approval based on postmarketing research.

Select one of the following:

True
False

Explanation

Question 6 of 12

1

Non-FDA-approved indications can be promoted by the manufacturer.

Select one of the following:

True
False

Explanation

Question 7 of 12

1

The FDA started allowing direct advertising in what year?

Select one of the following:

1985
1991
1995
1997

Explanation

Question 8 of 12

1

Drug prices: Suggested price determined by manufacturer is usually a different price (much lower) that is actually paid out-of-pocket by most consumers based on their insurance plan.

Select one of the following:

True
False

Explanation

Question 9 of 12

1

This phase in the drug development is tested on non-human subject

Select one of the following:

Phase 0
Phase 1
Phase 2
Phase 3
Phase 4

Explanation

Question 10 of 12

1

Which of the phases allow human trail?

Select one or more of the following:

Phase 0
Phase 1
Phase 2
Phase 3

Explanation

Question 11 of 12

1

Phase 1 trials allow 20-80 people (for safety, dosing range, and side effects). Phase 2 trials allow 100-300 people (for effective and further evaluation of safety). Phase 3 trials allow how many people (to confirm effectiveness, monitor side effects, and compared it to commonly used treatments)?

Select one of the following:

500-1000
1000-3000
4000-5000

Explanation

Question 12 of 12

1

Phase 4 trial - post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

Select one of the following:

True
False

	Created by Kevin Vu over 8 years ago