Pharmacology
9th Edition
Author(s)Rebecca G. Tucker
TEST BANK
Question 1
Clinical Scenario
A nursing student is attending an orientation at a
pharmaceutical research facility. During the session, the
educator explains that before a new medication is administered
,to human volunteers, extensive laboratory testing is conducted
using cell cultures and animal models to determine its basic
safety profile.
Question
Which stage of drug development is the educator describing?
Options
A. Phase I clinical trial
B. Preclinical trials
C. Phase II clinical trial
D. Phase III clinical trial
Correct Answer
B. Preclinical trials
Rationale
Preclinical trials are conducted before a medication is tested in
humans. Researchers evaluate pharmacologic activity, toxicity,
pharmacokinetics, and potential adverse effects using
laboratory and animal studies. Data from these studies help
determine whether a drug is safe enough to proceed to human
clinical trials.
Why the Other Options Are Incorrect
,A. Phase I clinical trials involve a small group of healthy
volunteers to evaluate safety, dosage range, and
pharmacokinetics in humans.
C. Phase II clinical trials evaluate the drug's effectiveness and
continue safety assessments in patients who have the targeted
disease.
D. Phase III clinical trials involve large populations to compare
the new medication with existing therapies and identify less
common adverse effects before regulatory approval.
Learning Objective
Differentiate preclinical testing from the phases of human
clinical drug evaluation.
Bloom's Taxonomy
Understand
Difficulty
Easy
NCLEX Client Needs Category
Physiological Integrity – Pharmacological and Parenteral
Therapies
NCJMM Clinical Judgment Skill
Recognize Cues
, Question 2
Clinical Scenario
A nurse is reviewing a patient's medication list. The patient asks
why the provider prescribed a medication for migraine
prevention when the package insert only lists treatment of
seizure disorders as an approved indication.
Question
What is the nurse's best response?
Options
A. "The medication was prescribed incorrectly because it is only
approved for seizures."
B. "Providers may legally prescribe medications for conditions
other than those listed on the FDA label when supported by
scientific evidence."
C. "The pharmacy dispensed the wrong medication."
D. "Only medications approved specifically for migraines may
legally be prescribed."
Correct Answer