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The study has been approved by local Ethical Committee according to national laws which allow the anonymous and aggregate use of human data if not involved in any experimental designs.
Potential ethical concerns derived from the use of human data were carefully considered; informed consent was not obtained as data was collected routinely for epidemiologic surveillance purposes.
In addition, the use of human data reduces uncertainty since assessment factors for interspecies extrapolation are superfluous when human data are used.
The use of human data is further reinforced by animal welfare considerations since the need to initiate animal testing is questionable if good quality data from human experiences are available.
Although an RfD can be calculated from either animal or human data, it is generally agreed that use of human data is appropriate whenever suitable human data are available.
In this study we explored the use of human data sets on exposure and noncancer end points in the context of an MOE approach to risk assessment for PCDD/PCDFs and toxic equivalent (TEQ)–contributing PCB compounds.
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Because some structural polymorphisms and mutations represent large-scale changes from the reference map, an iterative assembly process was used for the analysis of human data sets.
The (improved) in vitro models still needs validation, most likely using animal data, clearly alternative approaches need to be developed for this (making use of available human data).
The objective of this study was to a) provide an assessment of the degree of change in lipid-adjusted TEQ concentrations over the past three decades, and b) demonstrate the use of example human data sets in an MOE framework for assessing noncancer risks of dioxins and related compounds.
This manuscript does not report on or involve the use of any human data.
This article suggests the use of human capability data in a virtual environment to explore the level of acceptability of a working strategy based on real capability data (joint mobility in this case) of older workers.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com