Climate Change Data Portal
DOI | 10.1016/j.yrtph.2016.02.018 |
Micro-Cr imaging: Developing criteria for examining fetal skeletons in regulatory developmental toxicology studies - A workshop report | |
Solomon, Howard M.1; Makris, Susan L.2; Alsaid, Hasan1; Bermudez, Oscar3; Beyer, Bruce K.4; Chen, Antong5; Chen, Connie L.3; Chen, Zhou6; Chmielewski, Gary6; DeLise, Anthony M.8; de Schaepdrijver, Luc9; Dogdas, Belma5; French, Julian10; Harrouk, Wafa6; Helfgott, Jonathan11; Henkelman, R. Mark12; Hesterman, Jacob13; Hew, Kok-Wah14; Hoberman, Alan15; Lo, Cecilia W.16; McDougal, Andrew6; Minck, Daniel R.6; Scott, Lelia15; Stewart, Jane17; Sutherland, Vicki18; Tatiparthi, Arun K.7; Winkelmann, Christopher T.19; Wise, L. David; Wood, Sandra L.20; Ying, Xiaoyou21 | |
发表日期 | 2016-06-01 |
ISSN | 0273-2300 |
卷号 | 77页码:100-108 |
英文摘要 | During the past two decades the use and refinements of imaging modalities have markedly increased making it possible to image embryos and fetuses used in pivotal nonclinical studies submitted to regulatory agencies. Implementing these technologies into the Good Laboratory Practice environment requires rigorous testing, validation, and documentation to ensure the reproducibility of data. A workshop on current practices and regulatory requirements was held with the goal of defining minimal criteria for the proper implementation of these technologies and subsequent submission to regulatory agencies. Micro-computed tomography (micro-CT) is especially well suited for high-throughput evaluations, and is gaining popularity to evaluate fetal skeletons to assess the potential developmental toxicity of test agents. This workshop was convened to help scientists in the developmental toxicology field understand and apply micro-CT technology to nonclinical toxicology studies and facilitate the regulatory acceptance of imaging data. Presentations and workshop discussions covered: (1) principles of micro-CT fetal imaging; (2) concordance of findings with conventional skeletal evaluations; and (3) regulatory requirements for validating the system. Establishing these requirements for micro-CT examination can provide a path forward for laboratories considering implementing this technology and provide regulatory agencies with a basis to consider the acceptability of data generated via this technology. Published by Elsevier Inc. |
英文关键词 | Concordance criteria;Developmental toxicology;Imaging;Micro-CT;Skeletal evaluation;GLP validation |
语种 | 英语 |
WOS记录号 | WOS:000376812900012 |
来源期刊 | REGULATORY TOXICOLOGY AND PHARMACOLOGY
![]() |
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/61959 |
作者单位 | 1.GlaxoSmithKline, King Of Prussia, PA USA; 2.US EPA, Natl Ctr Environm Assessment, Washington, DC 20460 USA; 3.ILSI Hlth & Environm Sci Inst, Washington, DC USA; 4.Sanofi US Inc, Bridgewater, NJ USA; 5.Merck Res Labs, Kenilworth, NJ USA; 6.US FDA, Ctr Drug Evaluat & Res, Off New Drugs, Silver Spring, MD USA; 7.Covance Labs, Greenfield, IN USA; 8.Nova Pharmaceut Corp, E Hanover, NJ USA; 9.Janssen R&D, Beerse, Belgium; 10.Morphol Consulting Ltd, Stoke On Trent, Staffs, England; 11.Stage 2 Innovat, Framingham, MI USA; 12.Univ Toronto, Hosp Sick Children, Toronto, ON M5G 1X8, Canada; 13.InviCRO, Boston, MA USA; 14.Takeda Pharmaceut Co, Deerfield, IL USA; 15.Charles River Labs, Preclin Serv, Horsham, PA USA; 16.Univ Pittsburgh, Pittsburgh, PA USA; 17.ApconiX, Macclesfield, Cheshire, England; 18.Natl Toxicol Program NIEHS, Res Triangle Pk, NC USA; 19.Pfizer Worldwide Res & Dev, La Jolla, CA USA; 20.Merck Res Labs, Upper Gwynedd, PA USA; 21.Sanofi US Inc, Cambridge, MA USA |
推荐引用方式 GB/T 7714 | Solomon, Howard M.,Makris, Susan L.,Alsaid, Hasan,et al. Micro-Cr imaging: Developing criteria for examining fetal skeletons in regulatory developmental toxicology studies - A workshop report[J]. 美国环保署,2016,77:100-108. |
APA | Solomon, Howard M..,Makris, Susan L..,Alsaid, Hasan.,Bermudez, Oscar.,Beyer, Bruce K..,...&Ying, Xiaoyou.(2016).Micro-Cr imaging: Developing criteria for examining fetal skeletons in regulatory developmental toxicology studies - A workshop report.REGULATORY TOXICOLOGY AND PHARMACOLOGY,77,100-108. |
MLA | Solomon, Howard M.,et al."Micro-Cr imaging: Developing criteria for examining fetal skeletons in regulatory developmental toxicology studies - A workshop report".REGULATORY TOXICOLOGY AND PHARMACOLOGY 77(2016):100-108. |
条目包含的文件 | 条目无相关文件。 |
除非特别说明,本系统中所有内容都受版权保护,并保留所有权利。