Examples of validation of OOC and in vitro assays guided by regulatory bodies Sample Clauses

Examples of validation of OOC and in vitro assays guided by regulatory bodies. ‌ In the USA, the National Center for Advancing Translational Sciences (NCATS), a subsidiary of the National Institutes of Health (NIH), is leading efforts towards replacing animals for toxicity testing, disease modelling and efficacy testing. Together with other NIH Institutes and Centers, the Defense Advanced Research Projects Agency (DARPA) and the FDA have set up a program to develop human tissue chips to model the structure and function of human organs11. In the first phase, the development of 3D cellular microsystems was funded (2012-2014). Systems that showed physiological function successfully were then further refined (2015-2017). The project involves Tissue Chip Testing Centers, which are independent institutions and provide a way to test and qualify tissue chip platforms and promote adoption by the broader research community. The Tissue Chips for Disease Modelling initiative (1) supports development of in vitro disease models using primary tissue or induced pluripotent stem cell (iPSC)-derived cells from patient sources on tissue/OoC platforms, (2) determines the disease relevance of these models by preliminary testing of key experimental features and (3) tests the effectiveness of candidate drugs. Further, there is the Tox21 initiative, using robotics and other testing approaches to more efficiently predict how chemicals may affect human health (Xxxxxxx 2009). Tox21 is developing cell-based tests and biochemical approaches, which measure chemical substances produced in living organisms. Ultimately, these new strategies will help to quickly evaluate thousands of chemicals and support regulatory decisions about the safety of chemicals. Federal partners involved are the National Institute of Environmental Health Sciences (NIEHS)/National Toxicology Program (NTP), the NCATS, the FDA and the National Center for Computational Toxicology. The use of robots for handling of chemicals and cells drastically reduces the workload. Part of the data of the project was published in 2015 as computational efforts to predict toxicities of environmental compounds (Eduati et al. 2015).
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