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FDA Drug Evaluation and Approval Process Quiz

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FDA Drug Evaluation and Approval Process Quiz

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Questions and Answers

What is the purpose of phase I clinical studies?

To test the drug on healthy human volunteers (correct)

To test the drug in a vast market

To perform studies on animals

To evaluate the drug after FDA approval

Which schedule of controlled substances includes drugs with high abuse potential?

Schedule II (correct)

Schedule IV

Schedule I

Schedule III

What is the main characteristic of orphan drugs?

They are intended to treat a vast market

They have no acceptable medical usage

They involve continual evaluation after FDA approval

They only treat a small amount of people (correct)

What is the purpose of phase IV clinical studies?

To involve continual evaluation of the drug after FDA approval Signup and view all the answers

Which schedule of controlled substances includes drugs with limited abuse potential?

Schedule V Signup and view all the answers

What do phase II clinical studies involve?

Testing the drug on humans whom the drug was intended to treat Signup and view all the answers

What is the term for the time it takes for a drug to start to have a therapeutic response in the body?

Onset of drug action Signup and view all the answers

Which term describes the lowest level of drug concentration in the body?

Trough level Signup and view all the answers

What do we call the time it takes for the amount of a drug to be reduced to half of the peak level it originally achieved?

Half-life Signup and view all the answers

Which term refers to drugs that can attack only foreign cells, not body cells?

Selective toxicity Signup and view all the answers

What is the term for undesirable or unintended effects of a drug which can range from mild to life-threatening?

Adverse drug reactions Signup and view all the answers

Which term refers to drugs acting at receptor sites on cells and needing to fit like a lock and key?

Pharmacodynamics Signup and view all the answers

What phenomenon greatly reduces the concentration of an oral drug before it reaches systemic circulation due to rapid metabolism by the liver immediately after absorption?

First pass effect Signup and view all the answers

Which term refers to the time it takes for a drug to have a full therapeutic effect?

Peak effect Signup and view all the answers

What is the primary site for metabolism/biotransformation of drugs in the body?

Liver Signup and view all the answers

Which term refers to drugs demonstrating the ability to attack only foreign cells, not body cells?