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DOI10.1016/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
ISSN0273-2300
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
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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