02120nas a2200313   4500000000100000000000100001008004100002260001500043100002000058700001800078700001600096700002000112700001700132700001500149700002400164700002200188700002300210700002300233700001700256700001800273700001500291700001600306700001500322700002400337245010100361856007000462520126000532022001401792       2024                            d  c2024-02-151 aDarwin R. Reyes1 aMandy B. Esch1 aLorna Ewart1 aRohollah Nasiri1 aAnna Herland1 aKyung Sung1 aMonica Piergiovanni1 aCarolina Lucchesi1 aJames T. Shoemaker1 aJelena Vukasinovic1 aHiroki Nakae1 aJames Hickman1 aKapil Pant1 aAnne Taylor1 aNiki Heinz1 aNureddin Ashammakhi00aFrom animal testing to in vitro systems: advancing standardization in microphysiological systems  uhttps://pubs.rsc.org/en/content/articlelanding/2024/lc/d3lc00994g3 aLimitations with cell cultures and experimental animal-based studies have had the scientific and industrial communities searching for new approaches that can provide reliable human models for applications such as drug development, toxicological assessment, and in vitro pre-clinical evaluation. This has resulted in the development of microfluidic-based cultures that may better represent organs and organ systems in vivo than conventional monolayer cell cultures. Although there is considerable interest from industry and regulatory bodies in this technology, several challenges need to be addressed for it to reach its full potential. Among those is a lack of guidelines and standards. Therefore, a multidisciplinary team of stakeholders was formed, with members from the US Food and Drug Administration (FDA), the National Institute of Standards and Technology (NIST), European Union, academia, and industry, to provide a framework for future development of guidelines/standards governing engineering concepts of organ-on-a-chip models. The result of this work is presented here for interested parties, stakeholders, and other standards development organizations (SDOs) to foster further discussion and enhance the impact and benefits of these efforts.  a1473-0189