Strategies for Species Selection

For both small molecules and biopharmaceuticals, regulatory guidelines state that nonclinical safety testing should be conducted in both a rodent and a nonrodent species (ICH M3R2, 2009 ICH S6R1, 2011). For some 

From a practical perspective, species cross-reactivity should be considered an important criterion for lead candidate selection. In the absence of cross-reactivity, there are limited options for assessing the potential safety risks during nonclinical development, which in turn impacts the conduct of the clinical trials (Muller et al., 2009). Ideally, a lead candidate with both rodent and nonrodent cross-reactivity would be identified, as this enables the molecule to be evaluated in pharmacology studies and if needed early rodent toxicology studies. However, if not possible, all available protein engineering efforts should be undertaken to identify a lead with NHP CToss-reactivity (Doria-Rose and Joyce, 2015). 

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