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DOI10.1177/0192623318761348
Use of Severity Grades to Characterize Histopathologic Changes
Schafer, Kenneth A.1; Eighmy, John2; Fikes, James D.3; Halpern, Wendy G.4; Hukkanen, Renee R.5; Long, Gerald G.6; Meseck, Emily K.7; Patrick, Daniel J.8; Thibodeau, Michael S.9; Wood, Charles E.10; Francke, Sabine11
发表日期2018-04-01
ISSN0192-6233
卷号46期号:3页码:256-265
英文摘要

The severity grade is an important component of a histopathologic diagnosis in a nonclinical toxicity study that helps distinguish treatment-related effects from background findings and aids in determining adverse dose levels during hazard characterization. Severity grades should be assigned based only on the extent (i.e., amount and complexity) of the morphologic change in the examined tissue section(s) and be clearly defined in the pathology report for critical lesions impacting study interpretation. However, the level of detail provided and criteria by which severity grades are assigned can vary, which can lead to inappropriate comparisons and confusion when evaluating pathology results. To help address this issue, a Working Group of the Society of Toxicologic Pathology's Scientific and Regulatory Policy Committee was formed to provide a points to consider article on the assignment and application of pathology severity grades. Overall, the Working Group supports greater transparency and consistency in the reporting of grading scales and provides recommendations to improve selection of diagnoses requiring more detailed severity criteria. This information should enhance the overall understanding by toxicologic pathologists, toxicologists, and regulatory reviewers of pathology findings and thereby improve effective communication in regulatory submissions.


英文关键词histopathology;severity grades;severity scores;adversity;hazard;risk assessment
语种英语
WOS记录号WOS:000432138800002
来源期刊TOXICOLOGIC PATHOLOGY
来源机构美国环保署
文献类型期刊论文
条目标识符http://gcip.llas.ac.cn/handle/2XKMVOVA/61684
作者单位1.Vet Path Serv Inc, 6450 Castle Dr, Mason, OH 45040 USA;
2.Covance Labs Inc, Madison, WI USA;
3.Biogen, Cambridge, MA USA;
4.Genentech Inc, San Francisco, CA USA;
5.Eisai Inc, Andover, MA USA;
6.Expt Pathol Labs Inc, Sterling, VA USA;
7.Novartis Inst Biomed Res, E Hanover, NJ USA;
8.MPI Res, Mattawan, MI USA;
9.Boehringer Ingelheim Pharmaceut Inc, 90 E Ridge POB 368, Ridgefield, CT 06877 USA;
10.US EPA, Res Triangle Pk, NC 27711 USA;
11.US FDA, College Pk, MD USA
推荐引用方式
GB/T 7714
Schafer, Kenneth A.,Eighmy, John,Fikes, James D.,et al. Use of Severity Grades to Characterize Histopathologic Changes[J]. 美国环保署,2018,46(3):256-265.
APA Schafer, Kenneth A..,Eighmy, John.,Fikes, James D..,Halpern, Wendy G..,Hukkanen, Renee R..,...&Francke, Sabine.(2018).Use of Severity Grades to Characterize Histopathologic Changes.TOXICOLOGIC PATHOLOGY,46(3),256-265.
MLA Schafer, Kenneth A.,et al."Use of Severity Grades to Characterize Histopathologic Changes".TOXICOLOGIC PATHOLOGY 46.3(2018):256-265.
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