Drug Discovery + Principles of Pharm Flashcards
1
Q
What must happen before Phase I?
A
Pre-clinical testing and toxicology screen
2
Q
What happens in Phase I?
A
10 N volunteers receive small doses for safety
3
Q
What happens in Phase II?
A
small group of patients w disease and observe efficacy and safety
4
Q
What happens in Phase III?
A
large-scale clinical trial in pts w disease observed for best dosage for treatment of disease
5
Q
What happens in NDA (New Drug Application)?
A
if the FDA approves, the drug goes on the market for general use
