How are nonclinical safety study endpoints chosen under GLP?

• A. Based on regulatory guidance, study objectives, and scientific relevance; endpoints must be clearly defined and validated
• B. Based on personal preferences
• C. Based on vendor recommendations
• D. Endoints do not require validation

Answer: (A)

In GLP nonclinical safety studies, endpoints are chosen to reliably reveal potential toxic effects that are relevant to humans. The best approach is to base endpoint selection on regulatory guidance, the specific objectives of the study, and the scientific relevance of the endpoint. Each endpoint should be clearly defined, with the measurement method, timing, and acceptance criteria specified, and the endpoint's measurement approach must be validated to ensure accuracy and reproducibility. This combination ensures the data are credible and acceptable to regulators.

Choosing endpoints based on personal preferences or solely on vendor recommendations does not meet GLP standards, because such choices may lack regulatory justification and objective reliability. Endpoints also require validation or robust scientific justification to prove that the measurements are reliable and fit for purpose in detecting safety signals.