Nonclinical testing animal species

The animal species chosen for the later nonclinical safety studies should be responsive to the pharmacodynamic action(s). If the standard laboratory species are not responsive, the applicant should justify the choice of species selected or any supplementary tests if these are deemed appropriate. 

Nonclinical Studies In vitro (laboratory) or in vivo (animal) pharmacology, toxicology and pharmacokinetic studies that support the testing of a product in humans. Usually at least two species are evaluated prior to Phase I clinical trials. Nonclinical studies continue throughout all phases of research to evaluate long-term safety issues. 

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