16 Questions
What is the purpose of phase I clinical studies?
To test the drug on healthy human volunteers
Which schedule of controlled substances includes drugs with high abuse potential?
Schedule II
What is the main characteristic of orphan drugs?
They only treat a small amount of people
What is the purpose of phase IV clinical studies?
To involve continual evaluation of the drug after FDA approval
Which schedule of controlled substances includes drugs with limited abuse potential?
Schedule V
What do phase II clinical studies involve?
Testing the drug on humans whom the drug was intended to treat
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
Which term describes the lowest level of drug concentration in the body?
Trough level
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
Which term refers to drugs that can attack only foreign cells, not body cells?
Selective toxicity
What is the term for undesirable or unintended effects of a drug which can range from mild to life-threatening?
Adverse drug reactions
Which term refers to drugs acting at receptor sites on cells and needing to fit like a lock and key?
Pharmacodynamics
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
Which term refers to the time it takes for a drug to have a full therapeutic effect?
Peak effect
What is the primary site for metabolism/biotransformation of drugs in the body?
Liver
Which term refers to drugs demonstrating the ability to attack only foreign cells, not body cells?
Selective toxicity
Test your knowledge of the FDA drug evaluation and approval process, including preclinical studies, phase I, II, and III clinical studies, and the final decision by the FDA.
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