Which step in the drug approval process involves clinical trials?

The correct answer is the step that specifically involves clinical trials. Clinical trials are essential in the drug approval process as they consist of structured studies conducted in human subjects to evaluate the safety and efficacy of a new drug. This phase is critical as it assesses how the drug behaves in the human body, determines its pharmacokinetics, and looks for adverse effects, ultimately providing evidence that helps regulatory bodies decide whether to approve the drug for public use.

During this phase, the drug undergoes several trial phases, typically referred to as Phase 1, Phase 2, and Phase 3 trials, each with distinct goals and methodologies aimed at progressively evaluating the drug's safety and effectiveness. These trials follow the preclinical animal studies and precede the new drug application submission, making them pivotal in transitioning from laboratory research to real-world application in the healthcare system.

The other options refer to different steps in the drug approval process: animal studies provide initial data about the drug’s safety profile before human testing, the investigational new drug study is a preparatory step for initiating clinical trials, and the new drug application involves compiling all data and research results for review by regulatory authorities post-trial completion. None of these steps directly encompass the clinical trials component itself, which is