{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T23:34:38Z","timestamp":1787009678974,"version":"build-2736575974"},"reference-count":73,"publisher":"Oxford University Press (OUP)","issue":"1","funder":[{"DOI":"10.13039\/100000139","name":"U.S. Environmental Protection Agency","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000139","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,4,29]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The success and sustainability of U.S. EPA efforts to reduce, refine, and replace in vivo animal testing depends on the ability to translate toxicokinetic and toxicodynamic data from in vitro and in silico new approach methods (NAMs) to human-relevant exposures and health outcomes. Organotypic culture models employing primary human cells enable consideration of human health effects and inter-individual variability but present significant challenges for test method standardization, transferability, and validation. Increasing confidence in the information provided by these in vitro NAMs requires setting appropriate performance standards and benchmarks, defined by the context of use, to consider human biology and mechanistic relevance without animal data. The human thyroid microtissue (hTMT) assay utilizes primary human thyrocytes to reproduce structural and functional features of the thyroid gland that enable testing for potential thyroid-disrupting chemicals. As a variable-donor assay platform, conventional principles for assay performance standardization need to be balanced with the ability to predict a range of human responses. The objectives of this study were to (1) define the technical parameters for optimal donor procurement, primary thyrocyte qualification, and performance in the hTMT assay, and (2) set benchmark ranges for reference chemical responses. Thyrocytes derived from a cohort of 32 demographically diverse euthyroid donors were characterized across a battery of endpoints to evaluate morphological and functional variability. Reference chemical responses were profiled to evaluate the range and chemical-specific variability of donor-dependent effects within the cohort. The data-informed minimum acceptance criteria for donor qualification and set benchmark parameters for method transfer proficiency testing and validation of assay performance.<\/jats:p>","DOI":"10.1093\/toxsci\/kfae014","type":"journal-article","created":{"date-parts":[[2024,1,31]],"date-time":"2024-01-31T00:39:51Z","timestamp":1706661591000},"page":"89-107","source":"Crossref","is-referenced-by-count":6,"title":["Technical evaluation and standardization of the human thyroid microtissue assay"],"prefix":"10.1093","volume":"199","author":[{"given":"Briana","family":"Foley","sequence":"first","affiliation":[{"name":"Center for Computational Toxicology and Exposure, Office of Research and Development, U.S. Environmental Protection Agency , Research Triangle Park, North Carolina 27711, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristen","family":"Hopperstad","sequence":"additional","affiliation":[{"name":"Center for Computational Toxicology and Exposure, Office of Research and Development, U.S. Environmental Protection Agency , Research Triangle Park, North Carolina 27711, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Gamble","sequence":"additional","affiliation":[{"name":"Center for Computational Toxicology and Exposure, Office of Research and Development, U.S. Environmental Protection Agency , Research Triangle Park, North Carolina 27711, USA"},{"name":"Oak Ridge Institute for Science and Education , Oak Ridge, Tennessee 37831, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott G","family":"Lynn","sequence":"additional","affiliation":[{"name":"Office of Pesticide Programs, U.S. Environmental Protection Agency , Washington, District of Columbia 20460, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2340-0301","authenticated-orcid":false,"given":"Russell S","family":"Thomas","sequence":"additional","affiliation":[{"name":"Center for Computational Toxicology and Exposure, Office of Research and Development, U.S. Environmental Protection Agency , Research Triangle Park, North Carolina 27711, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0276-9716","authenticated-orcid":false,"given":"Chad","family":"Deisenroth","sequence":"additional","affiliation":[{"name":"Center for Computational Toxicology and Exposure, Office of Research and Development, U.S. Environmental Protection Agency , Research Triangle Park, North Carolina 27711, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,2,4]]},"reference":[{"key":"2024042916032612700_kfae014-B1","first-page":"e05311","article-title":"Guidance for the identification of endocrine disruptors in the context of regulations (EU) no 528\/2012 and (EC) no 1107\/2009","volume":"16","author":"Andersson","year":"2018","journal-title":"EFSA J"},{"key":"2024042916032612700_kfae014-B2","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1124\/dmd.105.006759","article-title":"Expression of cytochromes p450, conjugating enzymes and nuclear receptors in human hepatoma HepaRG cells","volume":"34","author":"Aninat","year":"2006","journal-title":"Drug Metab. 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