Megan R LaFollette, Szczepan W Baran, J Lowry Curley, Anne M Dickinson, Trivia Frazier, Nina Hobi, Ming-I Huang, Victoria Hutter, Benoît G C Maisonneuve, Graham A Marsh, Rhamiya Mahendran, Iris Müller, Xiaohua Qian, Dharaminder Singh, William R Thelin, Jelena Vukasinovic, Pelin L Candarlioglu, Clive S Roper
{"title":"The Use of MPS in Three Rs and Regulatory Applications: Perspectives From Developers on Stakeholder Responsibilities.","authors":"Megan R LaFollette, Szczepan W Baran, J Lowry Curley, Anne M Dickinson, Trivia Frazier, Nina Hobi, Ming-I Huang, Victoria Hutter, Benoît G C Maisonneuve, Graham A Marsh, Rhamiya Mahendran, Iris Müller, Xiaohua Qian, Dharaminder Singh, William R Thelin, Jelena Vukasinovic, Pelin L Candarlioglu, Clive S Roper","doi":"10.1177/02611929241310566","DOIUrl":null,"url":null,"abstract":"<p><p>Increasing the use of microphysiological systems (MPS) in Three Rs and regulatory applications is a nuanced but important goal, which would also help increase their scientific impact. There are three distinct and important stakeholder groups that each play a unique role in expediting the use of MPS for regulatory purpose - namely, commercial MPS developers, end-users and regulators. Additionally, non-profit organisations, such as the 3Rs Collaborative (3RsC), can help coordinate these efforts. This paper introduces the MPS Initiative, as organised by the 3RsC, and clarifies the potential for MPS to benefit all Three Rs. Key differences in the use of MPS-derived data for regulatory evidence of efficacy versus safety, and for various other contexts of use, are discussed. Finally, the results are presented from a survey of primarily commercial MPS developers, that collected their views on the realistic responsibilities of each stakeholder group. The results also highlight their key perspectives on the use of MPS, in the context of Three Rs and regulatory applications.</p>","PeriodicalId":55577,"journal":{"name":"Atla-Alternatives To Laboratory Animals","volume":"53 1","pages":"26-41"},"PeriodicalIF":2.4000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Atla-Alternatives To Laboratory Animals","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/02611929241310566","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Increasing the use of microphysiological systems (MPS) in Three Rs and regulatory applications is a nuanced but important goal, which would also help increase their scientific impact. There are three distinct and important stakeholder groups that each play a unique role in expediting the use of MPS for regulatory purpose - namely, commercial MPS developers, end-users and regulators. Additionally, non-profit organisations, such as the 3Rs Collaborative (3RsC), can help coordinate these efforts. This paper introduces the MPS Initiative, as organised by the 3RsC, and clarifies the potential for MPS to benefit all Three Rs. Key differences in the use of MPS-derived data for regulatory evidence of efficacy versus safety, and for various other contexts of use, are discussed. Finally, the results are presented from a survey of primarily commercial MPS developers, that collected their views on the realistic responsibilities of each stakeholder group. The results also highlight their key perspectives on the use of MPS, in the context of Three Rs and regulatory applications.
期刊介绍:
Alternatives to Laboratory Animals (ATLA) is a peer-reviewed journal, intended to cover all aspects of the development, validation, implementation and use of alternatives to laboratory animals in biomedical research and toxicity testing. In addition to the replacement of animals, it also covers work that aims to reduce the number of animals used and refine the in vivo experiments that are still carried out.