What’s Inside?
Nonclinical safety assessment of candidate drugs in animal model is pivotal and required by the regulatory agency to support clinical development (Investigational New Drug; IND) and human risk assessment (New Drug Application/Biologics License Application; NDA/BLA). Selection the human-relevant animal species for toxicity testing depends on indications and drug modalities (small molecule/New Chemical Entity: metabolic profile and/or pharmacological activity; large molecule/Biologics: presence of the intended human target) to predict potential adverse effects in humans. Recent regulatory guidelines emphasize the need to provide scientific justifications of animal species for toxicity testing before first-in-human (FIH) clinical trials.
Authors
Yafei Chen, MS Director of Toxicology, Altasciences, Columbia, MO
