15 Questions
What is the purpose of phase II clinical studies?
To test the drug on humans whom the drug was intended to treat
Which schedule of controlled substances has no acceptable medical usage?
Schedule I
What is the primary purpose of phase IV clinical studies?
To evaluate the drug after it has gained FDA approval
Which drugs fall under Schedule III of controlled substances?
Tylenol with codeine and testosterone
What are orphan drugs?
Drugs that will only treat a small amount of people
What kind of volunteers participate in phase I clinical studies?
Healthy human volunteers (no females of childbearing age)
What is the time it takes for a drug to have a full therapeutic effect known as?
Peak effect
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
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
What are the 8 rights of drug administration?
Right patient, right drug, right dose, right time
Which pharmacokinetic process refers to what the body does to the drug?
Metabolism/biotransformation
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
What is the lowest level of drug concentration in the body known as?
Trough level
What is the primary site for metabolism/biotransformation of drugs in the body?
Liver
What is the nurses' responsibility in drug therapy?
Drug administration, assessment of adverse effects, client education
Test your knowledge about the process of drug evaluation and approval by the FDA, including preclinical studies, phase I, II, and III clinical trials, and the final decision-making process by the FDA.
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