Early De-risking Strategy for Novel Biotherapeutics

摘要: Nonclinical to clinical correlations of biotherapeutics generally support the utility nonclinical studies for predicting adverse responses, if fidelity pharmacodynamics human is maintained in models. However, toxicities associated with immunomodulation—opportunistic infections, cytokine release syndrome, and other indirect outcomes immunomodulation—are less likely be predicted by routine studies. Predicting reactions further complicated rapidly expanding array modalities. In this chapter, we discuss safety considerations establishing profiles various modalities early development provide examples events, special emphasis on immunotoxicity. Special approaches immunotoxicity due on-target off-target ensure well-being healthy volunteers as well patients are also discussed. Novel scientifically appropriate additional necessary make informed drug decisions addition information gathered from