Which phase of the drug approval process focuses on safety in a small and healthy volunteer population?

Phase 1 Trials are critical in the drug approval process as they specifically focus on evaluating the safety and tolerability of a new drug in a small group of healthy volunteers. The primary objectives during this phase involve determining the pharmacokinetics (how the drug is absorbed, distributed, metabolized, and excreted in the body), as well as identifying any potential side effects that could arise from the administration of the drug.

The design of Phase 1 studies typically includes a limited number of participants, often ranging from 20 to 100 individuals, which allows researchers to closely monitor the effects of the drug without the confounding effects of a disease state that might be present in later phases. By using healthy volunteers, researchers can establish a baseline for safety before the drug is tested in larger populations, particularly those with health conditions that the drug is intended to treat.

This phase sets the groundwork for further trials, as the safety data collected here informs the design and ethical considerations of subsequent phases where the drug will be tested on larger, more diverse populations, including those with the target condition.