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DOI10.1016/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
ISSN0273-2300
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
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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