Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

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A study focusing on determining the ideal dose of a new investigational product for treating hypothyroidism is classified as which phase?

Phase I
Phase II
Phase III
Phase IV

The correct answer is: Phase II

The correct classification for a study aiming to determine the ideal dose of a new investigational product for treating hypothyroidism is Phase II. This phase is primarily concerned with evaluating the efficacy of the medication, along with dosing requirements, after initial safety has been established in Phase I trials. In Phase II, researchers often focus on different dose levels to find the most effective and safe dosage to treat the condition, which aligns with the objectives of the study described in the question. During Phase I, the focus is mainly on assessing safety and tolerability, often with small groups of healthy participants rather than those with the targeted condition. Therefore, the determination of the ideal dose, relevant to the effectiveness of the drug in patients suffering from hypothyroidism, positions the study firmly within Phase II. Phase III would involve larger trials that further evaluate effectiveness, monitor side effects, and compare the drug to commonly used treatments, while Phase IV studies occur after a drug has been marketed, focusing on long-term effectiveness and safety in diverse populations.