Clinical studies Flashcards
1
Q
Phase 0
A
Exploratory, to establish if agent will work as desired
2
Q
Phase 1
A
Determine basic pharmacological and toxicological information in humans especially on safety
3
Q
Phase II
A
Conducted on a larger number of patients to further evaluate the safety of the treatment and to determine how well it works
4
Q
Phase III
A
Involves a larger number of patients to assess risks and benefits
5
Q
Phase IV
A
Post-marketing strategy to determine if the drug works over time and if it works for purposes other than hat was intended for