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DOI | 10.1177/0192623318761348 |
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 |
ISSN | 0192-6233 |
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
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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. |
条目包含的文件 | 条目无相关文件。 |
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