CITI Training Practice Exam

Studying pharmacokinetics and pharmacodynamics of a new drug formulation in humans refers to which phase?

1. Phase 1

2. Phase 2

3. Phase 3

4. Phase 4

The correct answer is: Phase 1

Studying pharmacokinetics and pharmacodynamics in humans is part of the pre-clinical phase, which is also known as Phase 1 of drug development. This phase involves testing the drug in a small group of healthy volunteers to determine its safety and potential side effects. Phase 2 involves testing the drug in a larger group of patients with the targeted condition to further examine its safety and efficacy, while Phase 3 involves testing the drug in an even larger group of patients to confirm its effectiveness and monitor for any rare side effects. Phase 4 refers to post-marketing surveillance of the drug after it has been approved for use in the general population. Therefore, the correct answer is A Phase 1. Options B, C, and D all refer to different phases of clinical trials and are therefore incorrect.