Assignment task:
The ICH M3(R2) guidance, which outlines the body of nonclinical work which should be conducted with a novel therapeutic prior to the start of trials in humans. We have also discussed the concept of establishing the safe starting dose for first-in-human trials by completing toxicity studies, per FDA's "Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers."
The importance of animal/nonclinical safety studies in establishing a therapeutics' safety profile before trials in humans can begin. You might consider using one or two examples from your own research to demonstrate key aspects of the importance of preclinical safety work.