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DOI10.1016/j.yrtph.2017.08.019
Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications
Paini, Alicia1; Leonard, Jeremy A.2; Kliment, Tomas3; Tan, Yu-Mei4; Worth, Andrew1
发表日期2017-11-01
ISSN0273-2300
卷号90页码:104-115
英文摘要

Physiologically based kinetic (PBK) models are used widely throughout a number of working sectors, including academia and industry, to provide insight into the dosimetry related to observed adverse health effects in humans and other species. Use of these models has increased over the last several decades, especially in conjunction with emerging alternative methods to animal testing, such as in vitro studies and data-driven in silico quantitative-structure-activity-relationship (QSAR) predictions. Experimental information derived from these new approach methods can be used as input for model parameters and allows for increased confidence in models for chemicals that did not have in vivo data for model calibration. Despite significant advancements in good modelling practice (GMP) for model development and evaluation, there remains some reluctance among regulatory agencies to use such models during the risk assessment process. Here, the results of a survey disseminated to the modelling community are presented in order to inform the frequency of use and applications of PBK models in science and regulatory submission. Additionally, the survey was designed to identify a network of investigators involved in PBK modelling and knowledgeable of GMP so that they might be contacted in the future for peer review of PBK models, especially in regards to vetting the models to such a degree as to gain a greater acceptance for regulatory purposes. (C) 2017 The Authors. Published by Elsevier Inc.


英文关键词PBK models;Physiologically based kinetic models;Regulatory;Toxicology;Risk assessment;Alternatives methods
语种英语
WOS记录号WOS:000413886200012
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/60726
作者单位1.European Commiss, Joint Res Ctr, Directorate Hlth Consumers & Reference Mat, Via E Fermi 2749, I-21027 Ispra, Italy;
2.Oak Ridge Inst Sci & Educ, Oak Ridge, TN 37831 USA;
3.Klimeto, Fuzna 4, Roznava, Slovakia;
4.US EPA, Natl Res Lab, Res Triangle Pk, NC 27709 USA
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GB/T 7714
Paini, Alicia,Leonard, Jeremy A.,Kliment, Tomas,et al. Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications[J]. 美国环保署,2017,90:104-115.
APA Paini, Alicia,Leonard, Jeremy A.,Kliment, Tomas,Tan, Yu-Mei,&Worth, Andrew.(2017).Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications.REGULATORY TOXICOLOGY AND PHARMACOLOGY,90,104-115.
MLA Paini, Alicia,et al."Investigating the state of physiologically based kinetic modelling practices and challenges associated with gaining regulatory acceptance of model applications".REGULATORY TOXICOLOGY AND PHARMACOLOGY 90(2017):104-115.
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