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DOI | 10.1016/j.yrtph.2017.10.007 |
Framework for the quality assurance of 'omics technologies considering GLP requirements | |
Kauffmann, Hans-Martin1; Kamp, Hennicke1; Fuchs, Regine2; Chorley, Brian N.3; Deferme, Lize4; Ebbels, Timothy5; Hackermueller, Joerg6; Perdichizzi, Stefania7; Poole, Alan8; Sauer, Ursula G.9; Tollefsen, Knut E.10; Tralau, Tewes11; Yauk, Carole12; van Ravenzwaay, Ben1 | |
发表日期 | 2017-12-01 |
ISSN | 0273-2300 |
卷号 | 91页码:S27-S35 |
英文摘要 | 'Omics technologies are gaining importance to support regulatory toxicity studies. Prerequisites for performing 'omics studies considering GLP principles were discussed at the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Workshop Applying 'omics technologies in Chemical Risk Assessment. A GLP environment comprises a standard operating procedure system, proper pre-planning and documentation, and inspections of independent quality assurance staff. To prevent uncontrolled data changes, the raw data obtained in the respective 'omics data recording systems have to be specifically defined. Further requirements include transparent and reproducible data processing steps, and safe data storage and archiving procedures. The software for data recording and processing should be validated, and data changes should be traceable or disabled. GLP-compliant quality assurance of 'omics technologies appears feasible for many GLP requirements. However, challenges include (i) defining, storing, and archiving the raw data; (ii) transparent descriptions of data processing steps; (iii) software validation; and (iv) ensuring complete reproducibility of final results with respect to raw data. Nevertheless, 'omics studies can be supported by quality measures (e.g., GLP principles) to ensure quality control, reproducibility and traceability of experiments. This enables regulators to use 'omics data in a fit-for-purpose context, which enhances their applicability for risk assessment. (C) 2017 Elsevier Inc. |
英文关键词 | Good laboratory practice (GLP);Standard operating procedure;Independent quality assurance;Documentation;Data storage;Reproducibility;Raw data definition;Software validation;Quality assurance inspection |
语种 | 英语 |
WOS记录号 | WOS:000418784500004 |
来源期刊 | REGULATORY TOXICOLOGY AND PHARMACOLOGY
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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/61707 |
作者单位 | 1.BASF SE, RB-T-Z470, D-67056 Ludwigshafen, Germany; 2.Metanomics GmbH, Berlin, Germany; 3.US EPA, Washington, DC 20460 USA; 4.ExxonMobil Petr & Chem BVBA, Antwerp, Belgium; 5.Imperial Coll London, London, England; 6.UFZ Helmholtz Ctr Environm Res, Dept Mol Syst Biol, Leipzig, Germany; 7.Agcy Prevent Environm & Energy Arpae, Ctr Environm Toxicol, Emilia Romagna, Italy; 8.ECETOC, Auderghem, Belgium; 9.Sci Consultancy Anim Welf, Neubiberg, Germany; 10.Norwegian Inst Water Res NIVA, Oslo, Norway; 11.German Fed Inst Risk Assessment BfR, Dept Chem & Prod Safety, Berlin, Germany; 12.Hlth Canada, Environm Hlth Sci & Res Bur, Ottawa, ON, Canada |
推荐引用方式 GB/T 7714 | Kauffmann, Hans-Martin,Kamp, Hennicke,Fuchs, Regine,et al. Framework for the quality assurance of 'omics technologies considering GLP requirements[J]. 美国环保署,2017,91:S27-S35. |
APA | Kauffmann, Hans-Martin.,Kamp, Hennicke.,Fuchs, Regine.,Chorley, Brian N..,Deferme, Lize.,...&van Ravenzwaay, Ben.(2017).Framework for the quality assurance of 'omics technologies considering GLP requirements.REGULATORY TOXICOLOGY AND PHARMACOLOGY,91,S27-S35. |
MLA | Kauffmann, Hans-Martin,et al."Framework for the quality assurance of 'omics technologies considering GLP requirements".REGULATORY TOXICOLOGY AND PHARMACOLOGY 91(2017):S27-S35. |
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