Module 5 - Drug Approval Process

Question 1

Drug Targets:

Answer 1

May include things such as cancer cells, viruses, enzymes, or receptors on the surface of our own cells.

Question 2

High-Throughput Screening

Answer 2

A common way new drugs are discovered today. Utilizes robotics and high-speed computers to evaluate huge numbers of potential drug molecules quickly and efficiently.

Question 3

Clinical Studies

Answer 3

A process of drug development where a large percentage of potential compounds and molecules are eliminated. The compounds which pass these studies will be known as “candidate drugs”.

Question 4

IND Application

Answer 4

Before a drug may be tested in people in the U.S., an Investigation New Drug application must be filed with the FDA. This includes a very comprehensive report of the drug.

Question 5

Trials (Phases):

Answer 5

Phase 1 - Researchers establish the safety of the drug by evaluating its pharmacokinetic profile (such as side effects). These are done with a few healthy volunteers.

Phase 2 - The candidate drug is tested to find the efficacy, dose, and safety of the molecule. These are done with volunteers with the condition the drug will be used for.

Phase 3 - Thousands of volunteers with the condition take part in the trial in order to confirm that the drug works in diverse populations.

Question 6

New Drug Application

Answer 6

NDA must be filled out and submitted to the FDA after successful clinical trials. The FDA will review all data to approve (or disapprove) of the drug.

Question 7

Post-market Surveillance

Answer 7

Drugs are even monitored after being marketed by the FDA, and pharmaceutical companies must send long-term safety data to the FDA (Phase 4).

Question 8

Drug Approval Process

Answer 8

• Find a target
• Test for a compound to hit it
• Preclinical studies
• IND application approved
• Clinical Trials (Phases I, II, and III)
• NDA Approved
• Monitored Drug Use