Drug Approval Process

Question 1

In pharmaceutics, we learned about:

Answer 1

drug dosage forms and formulations
physiochemical properties of drugs

Question 2

The clinical trial that involves pre-formulation studies is

Answer 2

phase 1

Question 3

T/F: During the preclinical trials, healthy volunteers are tested against a drug candidate

Answer 3

false

Question 4

Which of the following drug approval steps must be carried out before the drug is marketed?

Answer 4

NDA submission
IND submission

Question 5

Identify the chronological steps involved in the drug approval process

Answer 5

drug discovery, preclinical studies, clinical trials, NDA submission

Question 6

The main purpose of conducting phase 1 clinical trials is to

Answer 6

assess the safety of the drug

Question 7

What is the FDA’s response time for an IND submission?

Answer 7

30 days

Question 8

T/F: CDER determines the OTC vs prescription status of the drug.

Answer 8

true

Question 9

Which of the following phases of clinical trials involve understanding the disease and choosing a target molecule?

Answer 9

pre-clinical

Question 10

What is the response time for the FDA to the review clock?

Answer 10

180 days

Question 11

Which of the following DFs/DDs have the longest duration of action?

Answer 11

ointment