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FDA Drug Evaluation and Approval Process

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FDA Drug Evaluation and Approval Process

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Questions and Answers

What is the purpose of phase II clinical studies?

To evaluate the drug after it has gained FDA approval

To test the drug on healthy human volunteers

To test the drug in a vast market

To test the drug on humans whom the drug was intended to treat (correct)

Which schedule of controlled substances has no acceptable medical usage?

Schedule I (correct)

Schedule II

Schedule III

Schedule IV

What is the primary purpose of phase IV clinical studies?

To evaluate drugs with high abuse potential

To test the drug in a vast market

To test the drug on healthy human volunteers

To evaluate the drug after it has gained FDA approval (correct)

Which drugs fall under Schedule III of controlled substances?

Tylenol with codeine and testosterone Signup and view all the answers

What are orphan drugs?

Drugs that will only treat a small amount of people Signup and view all the answers

What kind of volunteers participate in phase I clinical studies?

Healthy human volunteers (no females of childbearing age) Signup and view all the answers

What is the time it takes for a drug to have a full therapeutic effect known as?

Peak effect Signup and view all the answers

What is the phenomenon where the concentration of an oral drug is greatly reduced before it reaches systemic circulation due to rapid metabolism by the liver?

First pass effect Signup and view all the answers

Which term refers to the time it takes for the amount of the drug to be reduced to 1/2 of the peak level it originally achieved?

Half-life of a drug Signup and view all the answers

What are the 8 rights of drug administration?

Right patient, right drug, right dose, right time Signup and view all the answers

Which pharmacokinetic process refers to what the body does to the drug?

Metabolism/biotransformation Signup and view all the answers

In pharmacodynamics, drugs can act as agonists or competitive antagonists at the receptor site. Which term describes drugs that can interfere with enzyme systems?

Drug-enzyme reactions Signup and view all the answers

What is the lowest level of drug concentration in the body known as?

Trough level 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

What is the nurses' responsibility in drug therapy?

Drug administration, assessment of adverse effects, client education Signup and view all the answers