What does an Investigational New Drug (IND) application require?

The Investigational New Drug (IND) application is a crucial step in the process of bringing a new drug to market. It serves as a formal request to the Food and Drug Administration (FDA) to initiate a clinical trial and provides essential information that outlines both the proposed study and the drug's profile.

A detailed plan for the study, often referred to as the clinical trial protocol, is a central component of the IND application. This plan must include various elements such as the study's objectives, design, methodology, and statistical analysis, which together indicate how the trial will be conducted. Moreover, the IND must also contain comprehensive information about the investigational drug, including its pharmacology, chemistry, manufacturing practices, and any previous study results. This comprehensive documentation ensures that the FDA has sufficient information to evaluate the safety and effectiveness of the drug before clinical trials can begin.

In contrast, other options mentioned in the question do not encompass the full scope of what an IND requires. While participant lists, hospital approvals, and animal study results may play roles in the overall context of conducting clinical trials, none of these aspects are singularly sufficient to meet the comprehensive requirements outlined in an IND application. Thus, the correct answer emphasizes the necessity for a holistic approach to documenting both