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

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During the initial human dose selection, what is one of the main goals of the drug development phase?

Determine dosage forms
Assess long-term effects
Explore therapeutic efficacy
Establish marketing strategies

The correct answer is: Explore therapeutic efficacy

During the initial human dose selection, exploring therapeutic efficacy is a key goal of the drug development phase. This phase involves determining the appropriate dosage that not only elicits a pharmacological response but also provides an understanding of how effective the drug is at treating the intended condition. Assessing therapeutic efficacy in early trials helps guide subsequent dose escalations and adjustments, ensuring that the drug has the potential to benefit patients. This exploration will inform future phases of clinical trials and help to refine the drug’s use in a clinical setting. While determining dosage forms, assessing long-term effects, and establishing marketing strategies are important aspects of drug development overall, they do not directly focus on the immediate goal of evaluating how the drug performs in humans concerning its therapeutic effects. Therefore, the emphasis on exploring therapeutic efficacy is critical during this phase.