Nonclinical study

Nonclinical study – any biomedical investigation that does not involve human subjects. Instead, these studies are typically conducted using laboratory animals, cells, tissues, or computer models to evaluate pharmacological properties, safety, or efficacy of a pharmaceutical product, medical device, or intervention before it progresses to human trials.

Definitions

ICH E6(R2)

1.41 Nonclinical Study:

Biomedical studies not performed on human subjects .

Role of nonclinical studies

Nonclinical studies contribute to the drug development process by obtaining data on the mechanism of action, pharmacokinetics, toxicity, and potential adverse effects of investigational products. The insights gained from nonclinical studies are used to make decisions about whether it is safe to proceed to clinical trials in humans.

See also