气候变化领域集成服务门户(CCPortal): Characterizing "Adversity" of Pathology Findings in Nonclinical Toxicity Studies: Results from the 4th ESTP International Expert Workshop

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DOI	10.1177/0192623316642527
	Characterizing "Adversity" of Pathology Findings in Nonclinical Toxicity Studies: Results from the 4th ESTP International Expert Workshop
	Palazzi, Xavier 1; Burkhardt, John E.2; Caplain, Henri 1; Dellarco, Vicki ; Fant, Pierluigi 3; Foster, John R.4; Francke, Sabine 5; Germann, Paul 6; Groeters, Sibylle 7; Harada, Takanori 8; Harleman, Johannes 9; Inui, Kosei 10; Kaufmann, Wolfgang 11; Lenz, Barbara 12; Nagai, Hirofumi 13; Pohlmeyer-Esch, Gabriele 14; Schulte, Agnes 15; Skydsgaard, Mikala 16; Tomlinson, Lindsay 2; Wood, Charles E.17; Yoshida, Midori 18
发表日期	2016-08-01
ISSN	0192-6233
卷号	44 期号:6 页码:810-824
英文摘要	The identification of adverse health effects has a central role in the development and risk/safety assessment of chemical entities and pharmaceuticals. There is currently a need for better alignment regarding how nonclinical adversity is determined and characterized. The European Society of Toxicologic Pathology (ESTP) therefore coordinated a workshop to review available definitions of adversity, weigh determining and qualifying factors of adversity based on case examples, and recommend a practical approach to define and characterize adversity in toxicology reports, to serve as a valuable prerequisite for future organ- or lesion-specific workshops planned by the ESTP.
英文关键词	adversity;adverse effect;toxicologic pathology;LOAEL;NOAEL;hazard identification
语种	英语
WOS记录号	WOS:000381001300002
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/61943
作者单位	1.Sanofi, Vitry Sur Seine, France; 2.Pfizer Inc, Groton, CT 06340 USA; 3.WIL Res, Lyon, France; 4.Tox Path Sci, Congleton, Cheshire, England; 5.US FDA, College Pk, MD USA; 6.AbbVie, Ludwigshafen, Germany; 7.BASF, Ludwigshafen, Germany; 8.Inst Environm Toxicol, Ibaraki, Japan; 9.Fresenius Kabi, Bad Homburg, Germany; 10.Ishihara Sangyo Kaisha Ltd, Osaka, Japan; 11.Merck, Darmstadt, Germany; 12.Roche Pharmaceut Res & Early Dev, Basel, Switzerland; 13.Takeda Pharmaceut Co Ltd, Fujisawa, Kanagawa, Japan; 14.Kaleidis Consultancy, St Louis, France; 15.Fed Inst Risk Assessment, Berlin, Germany; 16.Novo Nordisk AS, Malov, Denmark; 17.US EPA, Off Res & Dev, Res Triangle Pk, NC 27711 USA; 18.Food Safety Commiss, Cabinet Off, Tokyo, Japan
推荐引用方式 GB/T 7714	Palazzi, Xavier,Burkhardt, John E.,Caplain, Henri,et al. Characterizing "Adversity" of Pathology Findings in Nonclinical Toxicity Studies: Results from the 4th ESTP International Expert Workshop[J]. 美国环保署,2016,44(6):810-824.
APA	Palazzi, Xavier.,Burkhardt, John E..,Caplain, Henri.,Dellarco, Vicki.,Fant, Pierluigi.,...&Yoshida, Midori.(2016).Characterizing "Adversity" of Pathology Findings in Nonclinical Toxicity Studies: Results from the 4th ESTP International Expert Workshop.TOXICOLOGIC PATHOLOGY,44(6),810-824.
MLA	Palazzi, Xavier,et al."Characterizing "Adversity" of Pathology Findings in Nonclinical Toxicity Studies: Results from the 4th ESTP International Expert Workshop".TOXICOLOGIC PATHOLOGY 44.6(2016):810-824.