The nurse assisting with Phase 1 drug studies is talking with a woman who asks, "Why can't I participate in this study?" What would be the nurse's best response?
Women are more prone to adverse effects from medications.
Drugs pose a greater risk to women of reproductive age.
Drugs affect women differently than they affect men.
Drugs are tested only on men because they are stronger.
The Correct Answer is B
Choice A rationale
It is not correct to say that women are more prone to adverse effects from medications than men. Adverse effects can vary based on individual responses, and gender is not the sole determinant.
Choice B rationale
Women of reproductive age are often excluded from early-phase drug trials due to the potential risks that experimental drugs could pose to developing fetuses. The reproductive risk needs to be carefully managed to avoid harm.
Choice C rationale
While it is true that drugs can affect women differently than men, this answer does not directly address the specific reason why women are excluded from Phase 1 studies, which is primarily due to the potential risks to reproductive health.
Choice D rationale
This is incorrect because drugs are not tested only on men because they are stronger. This statement is not scientifically accurate and does not reflect the principles of clinical trial design.
Nursing Test Bank
Naxlex Comprehensive Predictor Exams
Related Questions
Correct Answer is D
Explanation
Choice A rationale
Evidence of human fetal risk would categorize the drug as Category D or X, not Category B.
Choice B rationale
This statement aligns more with Category C drugs, where animal studies show adverse effects, but not Category B.
Choice C rationale
This describes Category A drugs, not Category B.
Choice D rationale
Category B drugs have shown no risk in animal studies but lack adequate human studies, fitting this description.
Correct Answer is B
Explanation
Choice A rationale
The rebound effect is typically associated with decongestants rather than topical nasal steroids. It occurs when nasal congestion worsens after stopping decongestant use.
Choice B rationale
Local ulceration is a potential adverse reaction to topical nasal steroids due to the localized irritation and thinning of the nasal mucosa with prolonged use.
Choice C rationale
Increased nasal drainage is not a common adverse reaction to topical nasal steroids. These medications typically reduce inflammation and decrease nasal drainage.
Choice D rationale
Suppression of healing is not an adverse reaction associated with topical nasal steroids. These drugs are more likely to reduce inflammation and promote healing of the nasal mucosa.
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