Author Question: Before marketing a new drug that has been approved for use based on clinical effectiveness and ... (Read 44 times)

rmenurse · **on:** Jul 23, 2018

Before marketing a new drug that has been approved for use based on clinical effectiveness and safety, the manufacturer wishes to study the potential new uses for the drug. This is an example of which phase of study?

a. Phase I
b. Phase II
c. Phase III
d. Phase IV

Question 2

A clinical drug trial is concluding a study of pharmacokinetics and safety of a drug in healthy individuals. The nurse will assist enrollment of participants into the next phase of the study and will include which subjects?

a. Healthy subjects
b. Healthy and ill subjects
c. Subjects with the disease the drug will treat
d. Subjects with other diseases

cpetit11 · **Reply #1 on:** Jul 23, 2018

Answer to Question 1

ANS: D
Phase IV studies are performed to examine potential new indications for approved drugs.

Answer to Question 2

ANS: C
After Phase I studies demonstrating drug safety and pharmacokinetics have been completed, the drug is tested on subjects who have the disease the drug will treat.