L6.Drug Development

Question 0

What are 4 steps required in performing a good clinical drug trial?

Answer 0

1. Careful Planning
2. Control Group
3. Double-blind format
4. Randomization

Question 1

Why might a drug company apply for an IND? What happens if the FDA approves the IND?

Answer 1

A drug company applies for an IND (Investigational New Drug Approval) when it has discovered a new molecule that could potentially be developed into a therapeutic drug. If approved, the company is granted a 17 yr patent in which they have the sole rights to develope and sell the drug.

Question 2

The office of orphan products development (OOPD) passed the FDA Orphaned Drug Act, what is the purpose of this law?

Answer 2

It is a tax benefit that promotes development of orphaned drugs that have shown promise in diagnoses or treatment of rare diseases or conditions.

Question 3

Phase 1 Clinical trials are meant to determine what? Describe the group of individuals studied.

Answer 3

Phase 1 studies are used to study the basic pharmicokinetics of a drug. It is a nonblinded study of healthy, ~25-30 yr old patients without the target disease. The subjects are closely monitored to avoid any potential health side-affects.

Question 4

In what phase of a drug trial is the drug generally first given to subjects with the target disease?

Answer 4

Phase II. Generally a small # ~200. Closely monitored. Drug may be given to patients with target disease in Phase I if drug has high potential toxicity.

Question 5

Following Phase III, what form does a drug company submit to the FDA in order to bring a drug to market?

Answer 5

NDA = New Drug Application

Question 6

What defines Phase IV of a drug trial?

Answer 6

Phase IV is post-marketing surveillance that allows rare side-affects or disorders caused by the drug to be picked up that might have been missed in a smaller controlled study. Drug may have3 to be pulled off the market if this is the case.