What term describes biomedical studies not performed on human subjects?

• A. Nonclinical Study
• B. Multicenter Trial
• C. Investigator
• D. Investigator's Brochure

Answer: (A)

This question hinges on distinguishing studies that involve people from those that don’t. Biomedical work done before any human subjects are involved falls under nonclinical (often called preclinical) studies. These are typically in vitro experiments or animal studies that evaluate safety, pharmacology, toxicology, and pharmacokinetics to support regulatory filings and inform first-in-human dosing. That’s why nonclinical study is the best term for studies not performed on humans.

The other options describe things that do involve people or are not studies themselves: a multicenter trial is a human study conducted at several sites; an investigator is a person conducting a study; an Investigator's Brochure is a regulatory document compiling data about a product, not a study type.