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 ["A","B","C","D"]
Explanation
a) Administering medications correctly is a fundamental part of the intervention stage, ensuring safe and effective drug therapy.
b) Monitoring the patient for therapeutic and adverse effects is essential to assess the drug’s effectiveness and identify any potential complications.
c) Educating the patient about the medications helps promote adherence and ensures the patient understands the drug’s purpose, potential side effects, and proper administration.
d) Documenting the administration and effects of the medications is crucial for maintaining accurate medical records, tracking patient response, and ensuring continuity of care.
Correct Answer is A
Explanation
a) Bioavailability refers to the proportion of the drug that reaches systemic circulation when administered by a particular route. The oral route typically has lower bioavailability than the intravenous route due to the first-pass metabolism in the liver. Therefore, when switching from an IV form to an oral form, the dose often needs to be higher to achieve the same therapeutic effect.
b) Pinocytosis is a form of endocytosis where cells absorb fluids and small molecules. While important in drug absorption, it is not the reason why oral doses are higher than IV doses.
c) Tachyphylaxis is a rapid tolerance to a drug after its administration, often requiring higher doses over time, but it does not directly explain the need for a higher oral dose.
d) Protein binding refers to how drugs bind to proteins in the blood, which can affect their distribution. However, this is not the main reason why oral doses are higher than IV doses.
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