Regulatory Affairs Certification (RAC) Practice Exam 2026 - Free RAC Practice Questions and Study Guide

The focus on the safety, dosage, and side effects of a drug in human subjects is characteristic of Phase 1 clinical trials. This initial phase of testing is vital for assessing how the drug interacts with the human body and establishing basic pharmacokinetic properties. During Phase 1, a small group of healthy volunteers is typically selected to explore the drug's safety profile, identify any potential side effects, and figure out the appropriate dosage ranges. The primary goal is to ensure that the drug does not produce harmful effects and to determine the maximum tolerated dose. This stage lays the groundwork for subsequent phases of clinical testing, where larger groups of patients with the targeted condition are involved, and additional efficacy and side effect data are gathered. Thus, Phase 1 is crucial in the early stages of drug development for ensuring patient safety.