Scientific and Regulatory Policy Committee Brief Communication: 2019 Survey on Use of Digital Histopathology Systems in Nonclinical Toxicology Studies

被引:5
作者
Forest, Thomas [1 ]
Aeffner, Famke [2 ]
Bangari, Dinesh S. [3 ]
Bawa, Bhupinder [4 ]
Carter, Jonathan [5 ]
Fikes, James [6 ]
High, Wanda B. [7 ]
Hayashi, Shim-Mo [8 ,9 ]
Jacobsen, Matthew [10 ]
McKinney, LuAnn [11 ]
Rudmann, Daniel [12 ]
Steinbach, Thomas [13 ]
Schumacher, Vanessa [14 ]
Turner, Oliver C. [15 ]
Ward, Jerrold M. [16 ]
Willson, Cynthia J. [17 ]
机构
[1] Merck & Co Inc, 770 Sumneytown Pike, West Point, PA 19486 USA
[2] Amgen Inc, San Francisco, CA USA
[3] Sanofi R&D, Framingham, MA USA
[4] AbbVie Inc, Chicago, IL USA
[5] Labcorp Early Dev Labs Ltd, Harrogate, England
[6] Biogen Inc, Cambridge, MA USA
[7] High Preclin Pathol Consulting, Rochester, NY USA
[8] Tokyo Univ Agr & Technol, Fuchu, Tokyo, Japan
[9] Natl Inst Hlth Sci, Kawasaki, Kanagawa, Japan
[10] AstraZeneca, Cambridge, England
[11] US FDA, Silver Spring, MD USA
[12] Charles River Labs Int Inc, Wilmington, MA USA
[13] Expt Pathol Labs Inc, Res Triangle Pk, NC USA
[14] F Hoffmann La Roche Ltd, Basel, Switzerland
[15] Novartis, E Hanover, NJ USA
[16] Global VetPathol, Montgomery Village, MD USA
[17] Inotiv RTP, Res Triangle Pk, NC USA
关键词
digital histopathology; GLP; peer review; Scientific and Regulatory Policy Committee; toxicology; whole-slide image; PATHOLOGY; VALIDATION;
D O I
10.1177/01926233221084621
中图分类号
R36 [病理学];
学科分类号
100104 ;
摘要
Histopathologic evaluation and peer review using digital whole-slide images (WSIs) is a relatively new medium for assessing nonclinical toxicology studies in Good Laboratory Practice (GLP) environments. To better understand the present and future use of digital pathology in nonclinical toxicology studies, the Society of Toxicologic Pathology (STP) formed a working group to survey STP members with the goal of creating recommendations for implementation. The survey was administered in December 2019, immediately before the COVID-19 pandemic, and the results suggested that the use of digital histopathology for routine GLP histopathology assessment was not widespread. Subsequently, in follow-up correspondence during the pandemic, many responding institutions either began investigating or adopting digital WSI systems to reduce employee exposure to COVID-19. Therefore, the working group presents the survey results as a pre-pandemic baseline data set. Recommendations for use of WSI systems in GLP environments will be the subject of a separate publication.
引用
收藏
页码:397 / 401
页数:5
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