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

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An important goal during the early trials is to determine which of the following?

  1. Patient enrollment strategies

  2. Market potential of the drug

  3. Safe duration of drug exposure

  4. Cost of development

The correct answer is: Safe duration of drug exposure

In the early trials of a drug, it is crucial to focus on establishing the safety profile of the drug, including understanding the safe duration of drug exposure. This involves assessing how long patients can be safely exposed to the drug without experiencing adverse effects or toxicity. Determining the safe duration is vital for developing treatment regimens, ensuring patient safety, and complying with regulatory requirements. While other aspects, such as patient enrollment strategies, market potential, and development costs, are important factors in the overall drug development process, the primary concern during early trials is confirming that the drug can be administered safely to participants over a defined period. Understanding the safety duration helps guide further clinical trial phases and the decision-making process for continuing development.