Before marketing a new drug that has been approved for use based on clinical effectiveness and safety, the manufacturer wishes to study the potential new uses for the drug. This is an example of which phase of study?
Phase I
Phase II
Phase III
Phase IV
The Correct Answer is D
a) Phase I studies focus on assessing the safety, dosing, and side effects of a drug in healthy volunteers, not its clinical effectiveness or potential new uses.
b) Phase II studies evaluate the drug's effectiveness and safety in a small group of patients with the targeted condition but do not focus on potential new uses.
c) Phase III studies are large-scale trials conducted to confirm the drug's effectiveness and safety before approval but do not typically involve studying new uses of the drug.
d) Phase IV studies occur after a drug has been approved and marketed. These studies, often called post-marketing surveillance, evaluate the drug's effectiveness and safety in the general population and investigate new potential uses or long-term effects.
Nursing Test Bank
Naxlex Comprehensive Predictor Exams
Related Questions
Correct Answer is A
Explanation
A. Assessment is the first phase of the nursing process, during which the nurse gathers relevant patient data, such as allergies and lab values, to ensure safe medication administration. This step helps identify potential risks and contraindications.
B. Evaluation occurs after the medication has been administered and involves assessing the patient's response to the drug. In this case, the nurse is reviewing information before administration, making evaluation an incorrect choice.
C. Implementation refers to carrying out the nursing interventions, such as actually administering the medication. Since the nurse is still reviewing data, this step has not yet been reached.
D. Planning involves setting goals and determining appropriate interventions, but it does not include the direct collection of patient data. Reviewing lab values and allergies falls under the assessment phase.
Correct Answer is B
Explanation
A. Duration of action refers to the length of time a drug remains effective after reaching the MEC, but it does not describe the time required to reach this threshold.
B. Onset of action is the time it takes for a drug to reach the minimum effective concentration (MEC) and begin producing a therapeutic effect. This is influenced by factors such as drug absorption and distribution.
C. Peak action time refers to the time at which the drug reaches its highest concentration in the bloodstream, not the time required to reach the MEC.
D. The time response curve is a graphical representation of a drug's effects over time but does not specifically define the time needed to reach the MEC.
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