Scientific and Regulatory Policy Committee Points to Consider: Primary Digital Histopathology Evaluation and Peer Review for Good Laboratory Practice (GLP) Nonclinical Toxicology Studies

被引:3
作者
Forest, Thomas [1 ]
Aeffner, Famke [2 ]
Bangari, Dinesh S. [3 ]
Bawa, Bhupinder [4 ]
Carter, Jonathan [5 ]
Fikes, James [6 ]
High, Wanda [7 ]
Hayashi, Shim-Mo [8 ,9 ]
Jacobsen, Matthew [10 ]
McKinney, LuAnn [11 ]
Rudmann, Daniel [12 ]
Steinbach, Thomas [13 ]
Schumacher, Vanessa [14 ]
Turner, Oliver [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, N Chicago, IL USA
[5] Labcorp Early Dev Labs Ltd, Harrogate, England
[6] Biogen Inc, 14 Cambridge Ctr, Cambridge, MA 02142 USA
[7] High Preclin Pathol Consulting, New York, NY USA
[8] Tokyo Univ Agr & Technol, Lab Vet Pathol, Fuchu, Tokyo, Japan
[9] Natl Inst Hlth Sci, Div Food Addit, Kawasaki, Kanagawa, Japan
[10] AstraZeneca, Clin Pharmacol & Safety Sci, BioPharmaceut R&D, Regulatory Safety Ctr Excellence, Cambridge, England
[11] US FDA, Ctr Drug Evaluat & Res, 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] GlobalVetPathol, Montgomery Village, MD USA
[17] Integrated Lab Syst, Res Triangle Pk, NC USA
关键词
digital pathology; Good Laboratory Practice; histopathology; nonclinical; peer review; Scientific and Regulatory Policy Committee; toxicology; whole-slide image; PATHOLOGY; VALIDATION;
D O I
10.1177/01926233221099273
中图分类号
R36 [病理学];
学科分类号
100104 ;
摘要
The Society of Toxicologic Pathology's Scientific and Regulatory Policy Committee formed a working group to consider the present and future use of digital pathology in toxicologic pathology in general and specifically its use in primary evaluation and peer review in Good Laboratory Practice (GLP) environments. Digital histopathology systems can save costs by reducing travel, enhancing organizational flexibility, decreasing slide handling, improving collaboration, increasing access to historical images, and improving quality and efficiency through integration with laboratory information management systems. However, the resources to implement and operate a digital pathology system can be significant. Given the magnitude and risks involved in the decision to adopt digital histopathology, this working group used pertinent previously published survey results and its members' expertise to create a Points-to-Consider article to assist organizations with building and implementing digital pathology workflows. With the aim of providing a comprehensive perspective, the current publication summarizes aspects of digital whole-slide imaging relevant to nonclinical histopathology evaluations, and then presents points to consider applicable to both primary digital histopathology evaluation and digital peer review in GLP toxicology studies. The Supplemental Appendices provide additional tabulated resources.
引用
收藏
页码:531 / 543
页数:13
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