What are 4 steps required in performing a good clinical drug trial?
- Careful Planning
- Control Group
- Double-blind format
Why might a drug company apply for an IND? What happens if the FDA approves the IND?
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.
The office of orphan products development (OOPD) passed the FDA Orphaned Drug Act, what is the purpose of this law?
It is a tax benefit that promotes development of orphaned drugs that have shown promise in diagnoses or treatment of rare diseases or conditions.
Phase 1 Clinical trials are meant to determine what? Describe the group of individuals studied.
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.
In what phase of a drug trial is the drug generally first given to subjects with the target disease?
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.
Following Phase III, what form does a drug company submit to the FDA in order to bring a drug to market?
NDA = New Drug Application
What defines Phase IV of a drug trial?
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.