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Regul Toxicol Pharmacol. 2013 Jun;66(1):116-29. doi: 10.1016/j.yrtph.2013.03.005. Epub 2013 Mar 25.

Case study illustrating the WHO IPCS guidance on characterization and application of physiologically based pharmacokinetic models in risk assessment.

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  • 1Institute of Population Health, University of Ottawa, 1 Stewart Street, Suite 309, Ottawa, ON, Canada K1N 6N5.


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.

Copyright © 2013 Elsevier Inc. All rights reserved.

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