NURS 3100 Exam 1 Practice

During which phase are drugs first tested on a small number of healthy volunteers to assess their safety, tolerability, pharmacokinetics, and pharmacodynamics?

1. Clinical Phase 1

2. Clinical Phase 2

3. Clinical Phase 3

4. Preclinical Investigation

The correct answer is: Clinical Phase 1

During Clinical Phase 1, drugs are first tested on a small number of healthy volunteers to assess their safety, tolerability, pharmacokinetics, and pharmacodynamics. This phase focuses on determining the drug's pharmacological actions in humans, including how the drug is absorbed, distributed, metabolized, and excreted in the body. It is crucial to conduct these initial trials in healthy individuals to observe the drug's effects before moving on to testing in patients with the target condition. Preclinical Investigation refers to the stage of testing that occurs before human trials and involves laboratory and animal studies to gather data on the drug's safety and efficacy. Clinical Phase 2 and Clinical Phase 3 involve testing the drug in patients with the target condition to further evaluate its safety and efficacy but are not the initial phase where drugs are first tested on healthy volunteers.