Clinical Development of Therapeutics

Question 1

1. Preclinical Studies

Answer 1

new drug tested on normal and cancer cell lines in lab; animal testing for efficacy and toxicity

Question 2

2. IND (investigational new drug) application

Answer 2

file IND with FDA for clinical testing in humans

Question 3

3. Phase I trial

Answer 3

designed to determine safe and appropriate dose for subsequent studies

Question 4

4. Phase II trial

Answer 4

determine the effectiveness and side effects of new drug in one type of cancer

Question 5

5. Phase III trial

Answer 5

evaluates effectiveness and compares it to best available standard treatment

Question 6

6. new drug application (NDA)

Answer 6

file with FDA and provide phase III results

Question 7

7. FDA approval

Answer 7

can take 1.5 years; afterwards can be marketed to public under a label

Question 8

8. phase IV trials

Answer 8

don’t always occur; determine long-term safety and effectiveness