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From Candidate to Approved Drug

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Questions and Answers

Which government agency needs to approve a drug for it to become a drug?

The Centers for Disease Control and Prevention
The National Institutes of Health
The Food and Drug Administration (correct)
The World Health Organization

What is a lead molecule?

A drug candidate that has been approved by the FDA
A drug candidate that shows promising activity in a lab setting (correct)
A drug candidate that has been tested on humans
A drug candidate that has completed preclinical trials

What is the purpose of preclinical trials?

To determine the activity of the drug candidate
To validate the drug candidate for FDA approval
To test the drug candidate on humans
To test the drug candidate on animals (correct)

What is the role of the lead molecule in preclinical clinical trials?

To validate the drug candidate for FDA approval (C) Signup and view all the answers

What properties should a lead molecule have for it to be tested in preclinical clinical trials?

Both the desired activity and other properties (B) Signup and view all the answers

Which of the following is the correct definition of drug discovery?

The process of identifying and validating a drug candidate for the treatment of a specific disease (A) Signup and view all the answers

What is the role of the FDA in drug discovery?

To approve drug candidates for use in the USA (D) Signup and view all the answers

What is a lead molecule in drug discovery?

A drug candidate that has been partially validated (A) Signup and view all the answers

What is the purpose of preclinical trials in drug discovery?

To test a drug candidate in animals (A) Signup and view all the answers

What does it mean for a drug candidate to be a 'hit molecule'?

It has shown promising activity in an activity screen (C) Signup and view all the answers

What is the first step in the process of target identification and lead identification?

Identifying the target protein or enzyme (D) Signup and view all the answers

What is the purpose of lead identification in drug design?

To find a molecule that binds to the target protein and makes it inactive (C) Signup and view all the answers

What is the main focus of target identification in drug design?

Identifying the target protein or enzyme (A) Signup and view all the answers

What does it mean for a molecule to be a lead in drug design?

It has certain activity and can bind to the target protein (B) Signup and view all the answers

What are the two main steps involved in the process of target identification and lead identification?

Identifying the target protein or enzyme and finding a molecule that binds to it (D) Signup and view all the answers