Advances in Preclinical Toxicology: Bridging In Vitro, In Vivo, and Translational Gaps

Abstract

Even in the early days of medical progress, drug safety is at issue. In the past, it was fashionable to use animal testing, but it is expensive, ethically flawed, and it does not replicate human reactions. Researchers are therefore resorting to alternatives like in vitro (laboratory cell tests) and in silico (computer modelling).In vitro methods include the study of drug actions on cultured cells from humans to identify toxicity, whereas in silico methods rely on mathematical models, machine learning, and simulations to forecast a drug's behaviour and toxic profile.This review emphasizes new developments in the combination of in vitro and in silico toxicology strategies for the prediction of in vivo toxic effects in early drug discovery. It discusses major studies using these approaches, their limitations in extrapolating to humans, and opportunities of new technologies such as organ-on-chip systems and PBPK modelling. It emphasizes the growing importance of combining human-relevant laboratory models with advanced computational approaches to further anticipate safety, reduce animal usage, and accelerate the rate at which safer, better drugs appear in the clinic.