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DOI10.1016/j.tiv.2017.11.016
In vitro to in vivo extrapolation for high throughput prioritization and decision making
Bell, Shannon M.1; Chang, Xiaoqing1; Wambaugh, John F.2; Allen, David G.1; Bartels, Mike3,16; Brouwer, Kim L. R.4; Casey, Warren M.5; Choksi, Neepa1; Ferguson, Stephen S.6; Fraczkiewicz, Grazyna7; Jarabek, Annie M.2,9; Ke, Alice8; Lumen, Annie; Lynn, Scott G.10; Paini, Alicia11; Price, Paul S.2; Ring, Caroline12,17; Simon, Ted W.13; Sipes, Nisha S.6; Sprankle, Catherine S.1; Strickland, Judy1; Troutman, John14; Wetmore, Barbara A.15,18; Kleinstreuer, Nicole C.5
发表日期2018-03-01
ISSN0887-2333
卷号47页码:213-227
英文摘要

In vitro chemical safety testing methods offer the potential for efficient and economical tools to provide relevant assessments of human health risk. To realize this potential, methods are needed to relate in vitro effects to in vivo responses, i.e., in vitro to in vivo extrapolation (IVIVE). Currently available IVIVE approaches need to be refined before they can be utilized for regulatory decision-making. To explore the capabilities and limitations of IVIVE within this context, the U.S. Environmental Protection Agency Office of Research and Development and the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods co-organized a workshop and webinar series. Here, we integrate content from the webinars and workshop to discuss activities and resources that would promote inclusion of IVIVE in regulatory decision-making. We discuss properties of models that successfully generate predictions of in vivo doses from effective in vitro concentration, including the experimental systems that provide input parameters for these models, areas of success, and areas for improvement to reduce model uncertainty. Finally, we provide case studies on the uses of IVIVE in safety assessments, which highlight the respective differences, information requirements, and outcomes across various approaches when applied for decision-making.


英文关键词IVIVE;High throughput testing;Toxicity testing;Toxicokinetic;Computational toxicology;Risk assessment
语种英语
WOS记录号WOS:000426409400023
来源期刊TOXICOLOGY IN VITRO
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/61913
作者单位1.Integrated Lab Syst Inc, POB 13501, Res Triangle Pk, NC 27709 USA;
2.US EPA, 109 TW Alexander Dr, Res Triangle Pk, NC 27709 USA;
3.Dow Chem Co USA, Saginaw, MI 48603 USA;
4.Univ N Carolina, UNC Eshelman Sch Pharm, Campus Box 7569, Chapel Hill, NC 27599 USA;
5.NIEHS, Natl Toxicol Program, Interagency Ctr Evaluat Alternat Toxicol Methods, POB 12233, Res Triangle Pk, NC 27709 USA;
6.NIEHS, Natl Toxicol Program, POB 12233, Res Triangle Pk, NC 27709 USA;
7.Simulat Plus Inc, 42505 10th St West, Lancaster, CA 93534 USA;
8.Simcyp Ltd, John St, Sheffield S2 4SU, S Yorkshire, England;
9.US FDA, Natl Ctr Toxicol Res, 3900 NCTR Rd, Jefferson, AR 72079 USA;
10.US EPA, William Jefferson Clinton Bldg,1200 Penn Ave NW, Washington, DC 20460 USA;
11.European Commiss, Chem Safety & Alternat Methods Unit Incorporating, Directorate Hlth Consumers & Reference Mat, Joint Res Ctr,EURL ECVAM, Via E Fermi 2749, I-20127 Ispra, Varese, Italy;
12.Oak Ridge Inst Sci & Educ, POB 2008, Oak Ridge, TN 37831 USA;
13.Ted Simon LLC, 4184 Johnston Rd, Winston, GA 30187 USA;
14.Procter & Gamble Co, Cent Prod Safety, Cincinnati, OH 45202 USA;
15.ScitoVat LLC, 6 Davis Dr, Res Triangle Pk, NC 27709 USA;
16.ToxMetr Com, 2407 Wilmington Dr, Midland, MI 48642 USA;
17.ToxStrategies, Austin, TX 78759 USA;
18.US EPA, 109 TW Alexander Dr, Res Triangle Pk, NC 27709 USA
推荐引用方式
GB/T 7714
Bell, Shannon M.,Chang, Xiaoqing,Wambaugh, John F.,et al. In vitro to in vivo extrapolation for high throughput prioritization and decision making[J]. 美国环保署,2018,47:213-227.
APA Bell, Shannon M..,Chang, Xiaoqing.,Wambaugh, John F..,Allen, David G..,Bartels, Mike.,...&Kleinstreuer, Nicole C..(2018).In vitro to in vivo extrapolation for high throughput prioritization and decision making.TOXICOLOGY IN VITRO,47,213-227.
MLA Bell, Shannon M.,et al."In vitro to in vivo extrapolation for high throughput prioritization and decision making".TOXICOLOGY IN VITRO 47(2018):213-227.
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