A clinical drug trial is conducting a study of pharmacokinetics and safety of a drug in healthy individuals. The nurse will assist enrollment of participants into the next phase of the study and will include which subject?
Healthy and ill subjects
Subjects with other diseases
Subjects with disease the drug will treat
Healthy subjects
The Correct Answer is C
A. Phase I trials focus on healthy individuals, but the next phase (Phase II) involves patients with the target disease. Including both healthy and ill subjects at this stage is not appropriate.
B. Subjects with other diseases are not included in Phase II trials because the goal is to test the drug in individuals who have the specific condition the drug is intended to treat.
C. Phase II clinical trials focus on evaluating the drug’s efficacy and safety in individuals who have the disease it is designed to treat. This phase helps determine the optimal dosage and potential side effects in the target population.
D. Healthy subjects are included in Phase I trials to assess safety and pharmacokinetics, but in the next phase (Phase II), the study shifts to testing the drug in patients with the disease it is meant to treat.
Nursing Test Bank
Naxlex Comprehensive Predictor Exams
Related Questions
Correct Answer is D
Explanation
a) "Signature" and "hospital" are not part of the six rights of medication administration. The correct rights ensure patient safety by verifying essential aspects of drug administration.
b) "Solution," "doctor," and "shift" are not part of the six rights. The focus should be on ensuring the correct patient receives the right medication in the right manner.
c) "Order" and "signature" are important for verifying prescriptions, but they are not included in the six rights of administration.
d) The six rights of medication administration are right medication, right dosage, right route, right time, right client (patient), and right documentation. These ensure medication safety and prevent errors.
Correct Answer is D
Explanation
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.
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