Good Laboratory Practices regulations apply to non-clinical studies.

• A. True
• B. False
• C. Only clinical trials
• D. Not applicable

Answer: (A)

GLP regulations govern how nonclinical safety studies are planned, conducted, and reported to ensure the data are credible for regulatory decisions. These rules apply to studies conducted outside of humans—such as animal toxicity tests and many in vitro assays—so that the results can reliably support safety evaluations and regulatory submissions. The statement is true because GLP is specifically about nonclinical work, while human studies fall under Good Clinical Practice rather than GLP. The other options misstate the scope or applicability, since GLP does apply to nonclinical work and is not limited to clinical trials or completely not applicable.