What is the focus of an Investigational New Drug (IND) application?

An Investigational New Drug (IND) application primarily focuses on obtaining permission for human testing of unapproved drugs. When a drug developer wishes to begin clinical trials involving human subjects, they must submit an IND application to the Food and Drug Administration (FDA). This application includes detailed information about the drug, such as its composition, manufacturing process, and the proposed clinical trial protocols. The goal is to demonstrate that the drug can be tested safely in humans, thus ensuring the safety and efficacy of the drug before it is marketed.

This process is crucial for protecting participants in clinical trials, as it allows the FDA to review the intended use of the drug, the qualifications of the investigators, and the plans for monitoring the safety of participants. By requiring this step, the FDA ensures that ethical standards in clinical testing are upheld and that the risks are minimized.

In contrast, the other options focus on aspects unrelated to the primary purpose of an IND application. For example, obtaining approval for new marketing strategies and establishing a drug's market price pertains to commercialization, while ensuring compliance with post-market regulations relates to the oversight of drugs that are already on the market. These elements are vital in their own right, but they do not pertain to the initial step of assessing a drug’s