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DOI | 10.1016/j.yrtph.2013.03.005 |
Case study illustrating the WHO IPCS guidance on characterization and application of physiologically based pharmacokinetic models in risk assessment | |
Meek, M. E. (Bette)1; Barton, Hugh A.2; Bessems, Jos G.3; Lipscomb, John C.4; Krishnan, Kannan5 | |
发表日期 | 2013-06-01 |
ISSN | 0273-2300 |
卷号 | 66期号:1页码:116-129 |
英文摘要 | The World Health Organization (WHO) International Programme on Chemical Safety (IPCS) Guidance on Characterization and Application of Physiologically Based Pharmacokinetic Models in Risk Assessment (IPCS, 2010) describes key principles for risk assessors and model developers. In the WHO Guidance, a template for model documentation was developed and a case study included. Here the WHO Guidance, including the template, is summarized and an additional case study is presented to illustrate its application, based upon an existing risk assessment for 2-butoxyethanol (CAS NO. 111-76-2). The goal of the WHO Guidance and the current paper is to increase regulatory acceptance of complex biologically descriptive pharmacokinetic (or toxicokinetic) models, such as PBPK models, by facilitating communication and successful interaction between modelers and risk assessors. (C) 2013 Elsevier Inc. All rights reserved. |
英文关键词 | Risk assessment;Physiologically based pharmacokinetic (PBPK) modeling;2-Butoxyethanol |
语种 | 英语 |
WOS记录号 | WOS:000319087300015 |
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/60773 |
作者单位 | 1.Univ Ottawa, Inst Populat Hlth, Ottawa, ON K1N 6N5, Canada; 2.Pfizer Worldwide Res & Dev, Pharmacokinet Dynam & Metab, Groton, CT 06340 USA; 3.Natl Inst Publ Hlth & Environm RIVM, NL-3720 BA Bilthoven, Netherlands; 4.US EPA, Natl Ctr Environm Assessment, Off Res & Dev, Cincinnati, OH 45268 USA; 5.Univ Montreal, Dept Sante Environm & Sante Travail, Montreal, PQ H3T 1A8, Canada |
推荐引用方式 GB/T 7714 | Meek, M. E. ,Barton, Hugh A.,Bessems, Jos G.,et al. Case study illustrating the WHO IPCS guidance on characterization and application of physiologically based pharmacokinetic models in risk assessment[J]. 美国环保署,2013,66(1):116-129. |
APA | Meek, M. E. ,Barton, Hugh A.,Bessems, Jos G.,Lipscomb, John C.,&Krishnan, Kannan.(2013).Case study illustrating the WHO IPCS guidance on characterization and application of physiologically based pharmacokinetic models in risk assessment.REGULATORY TOXICOLOGY AND PHARMACOLOGY,66(1),116-129. |
MLA | Meek, M. E. ,et al."Case study illustrating the WHO IPCS guidance on characterization and application of physiologically based pharmacokinetic models in risk assessment".REGULATORY TOXICOLOGY AND PHARMACOLOGY 66.1(2013):116-129. |
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