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Therefore, alternative hepatocyte models based on cancer cell lines, such as human hepatoblastoma HepG2 cells, have been developed to provide more accessible and scalable systems for in vitro studies

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Phase III trials now include 42% more procedures and 37% more endpoints compared to a decade ago A significant portion of collected data is not directly tied to primary endpoints, adding operational burden without improving outcomes According to Tufts Center for the Study of Drug Development, complexity continues to increase across all phases, affecting timelines, costs, and site workload For sponsors, this translates into longer start-up timelines, more amendments, and increased execution risk

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It is primarily marketed and sold for research purposes only, and its regulatory status indicates that it is not regulated by the FDA or similar bodies for human use