What does Step 2 in the drug approval process focus on?

Step 2 in the drug approval process focuses on human clinical trials. This phase is crucial as it assesses the drug's safety and effectiveness in humans after preliminary data from animal studies are obtained. During this stage, the drug undergoes several phases of clinical trials involving different participant groups, which helps researchers understand how well the drug works, its side effects, optimal dosing, and overall safety profile.

The significance of human clinical trials lies in understanding human responses to the drug, gathering data for potential side effects, and determining if the benefits outweigh the risks. This information is vital as it will be submitted to regulatory bodies, allowing the drug to advance in the approval process.

While other phases such as animal studies and the new drug application submission are important, they are not the focus of Step 2. The investigational new drug study essentially encompasses the entire process but is not a specific focus of Step 2. In contrast, Step 2 is dedicated to gathering human data, which is essential for eventual market approval.