The human health risk assessment and management plan in early clinical phase is based on a weight of evidences approach, integrating knowledge of the therapeutic agent from in vivo animal toxicology studies, mechanism of action, and class effect. This session will cover some of the needs and potential limitations of this translational approach with a particular focus on the interpretation of toxicity testing. Topics will address the dilemma for industries for the clinical development of drug-induced non-monitorable toxicity, focusing on vasculitis; cover the supportive information generated from nonclinical assessment of blood pressure changes, reviewing current challenges, new technologies, and translation to human; and discuss the importance of nonclinical juvenile animal guidance in pediatric drug development, sharing real-world experience.