DECEMBER - JANUARY9TECH OUTLOOKand the downstream signaling pathways are all important aspects of PD that have an impact the dose-exposure-response relationship. In the early stages the safety is assessed by determining the adverse events of the drug in animal in vivo models. This helps to identify potential toxicity alerts before the drug is tested in humans. In early drug discovery, researchers use multiple models involving in silico, in vitro and to in vivo tools to characterize the complex dose-exposure-response relationship, and there is an urgent need for better performing models in terms of speed and better human prediction. Organ-on-chip (OOC) tools are interesting new technologies to understand better and guide the DMPK & Safety in early drug discovery. OCC models involve microfluidic devices that mimic the function of human organs. OOCs contain living cells that are cultured in a controlled environment to assess the toxicity and efficacy of drugs, but also allow to study DMPK processes such as drug metabolism and transport. These models enable the control of the cell environment, such as mimicking the flow of blood. The use of OOC in drug discovery has a promise to provide several advantages over traditional in vitro methods, including 2D cell-based assays or animal in vivo studies, e.g. to study of metabolic processes in a more patient relevant manner. They also allow for the explore multi-organ interaction of drugs, like the liver and the gut, in a controlled and reproducible manner. In addition, OOC is expected to reduce the use of animal studies in drug discovery. Organ-on-chip technology is an exciting and rapidly evolving field that has the potential to remarkable to speed up, increase the confidence of preclinical models and reduce costs in safety and efficacy testing of drugs and chemicals. As with all novel technologies there are still several limitations with the OOC. One of the challenges is the scalability in terms of through-put of the models; the current applications are still somewhat focused in specific questions in particular organs. Furthermore, the bulk experience for multiple chemical compound and biological effects is still evolving, which may be a challenge for the regulatory agencies. Continuing efforts are expected regarding expertise from the biology, engineering, and the data science.In summary, understanding DMPK and safety is extremely important in the drug discovery. By these understanding the relationship between dose-exposure-response can be more reliably assessed leading to more efficient discovery process. Therefore, there is an urgent need for developing of new methods and tools, where one of the most promising is Organ-On-Chip technology. Riikka OksalaAlthough researchers use multiple models involving in-silico models, in-vitro and in-vivo tools to characterize the complex dose-exposure-response relationship in early drug discovery, there is an urgent need for better performing models in terms of speed and better prediction
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