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From animal testing to in vitro systems: advancing standardization in microphysiological systems
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- Reyes, Darwin R. (author)
- National Institute of Standards and Technology (NIST) Gaithersburg MD USA
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- Esch, Mandy B. (author)
- National Institute of Standards and Technology (NIST) Gaithersburg MD USA
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- Ewart, Lorna (author)
- Emulate, Inc., Boston Massachusetts USA
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- Nasiri, Rohollah (author)
- KTH,Nanobioteknologi
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- Herland, Anna (author)
- KTH,Nanobioteknologi
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- Sung, Kyung (author)
- Food and Drug Administration (FDA) Silver Spring Maryland USA
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- Piergiovanni, Monica (author)
- European Commission, Joint Research Centre (JRC), Ispra Italy
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- Lucchesi, Carolina (author)
- BioneXus Foundation, ATCC, Manassas VA USA
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- Shoemaker, James T. (author)
- Lena Biosciences, Inc., Atlanta Georgia USA
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- Vukasinovic, Jelena (author)
- Lena Biosciences, Inc., Atlanta Georgia USA
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- Nakae, Hiroki (author)
- JMAC Japan bio Measurement & Analysis Consortium Tokyo Japan
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- Hickman, James (author)
- Hesperos, Inc., Orlando Florida USA
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- Pant, Kapil (author)
- SynVivo, Inc., Huntsville Alabama USA
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- Taylor, Anne (author)
- Xona Microfluidics, Inc., Research Triangle Park, North Carolina USA
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- Heinz, Niki (author)
- Altis Biosystems, Inc., Durham North Carolina USA
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- Ashammakhi, Nureddin (author)
- Institute for Quantitative Health Science and Engineering, Department of Biomedical Engineering, College of Engineering, and College of Human Medicine, Michigan State University, East Lansing MI USA
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National Institute of Standards and Technology (NIST) Gaithersburg MD USA Emulate, Inc, Boston Massachusetts USA (creator_code:org_t)
- Royal Society of Chemistry (RSC), 2024
- 2024
- English.
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In: Lab on a Chip. - : Royal Society of Chemistry (RSC). - 1473-0197 .- 1473-0189. ; 24:5, s. 1076-1087
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- Limitations 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine (hsv//eng)
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- By the author/editor
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Reyes, Darwin R.
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Esch, Mandy B.
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Ewart, Lorna
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Nasiri, Rohollah
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Herland, Anna
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Sung, Kyung
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Piergiovanni, Mo ...
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Lucchesi, Caroli ...
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Shoemaker, James ...
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Vukasinovic, Jel ...
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Nakae, Hiroki
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Hickman, James
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Pant, Kapil
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Taylor, Anne
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Heinz, Niki
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Ashammakhi, Nure ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
- Articles in the publication
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Lab on a Chip
- By the university
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Royal Institute of Technology