Application of Mass Balance Models and the Chemical Activity Concept To Facilitate the Use of in Vitro Toxicity Data for Risk Assessment

2014 ◽  
Vol 48 (16) ◽  
pp. 9770-9779 ◽  
Author(s):  
James M. Armitage ◽  
Frank Wania ◽  
Jon A. Arnot
Keyword(s):  
Risk Assessment ◽  
Mass Balance ◽  
Chemical Activity ◽  
In Vitro Toxicity ◽  
Toxicity Data ◽  
Mass Balance Models

The point of transition on the dose-effect curve as a reference point in the evaluation of in vitro toxicity data

2012 ◽  
Vol 32 (10) ◽  
pp. 843-849 ◽  
Author(s):  
Salomon Sand ◽  
Joakim Ringblom ◽  
Helen Håkansson ◽  
Mattias Öberg
Keyword(s):  
Reference Point ◽  
Dose Effect ◽  
In Vitro Toxicity ◽  
Toxicity Data ◽  
Effect Curve

scholarly journals Development of the SciRAP Approach for Evaluating the Reliability and Relevance of in vitro Toxicity Data

2021 ◽  
Vol 3 ◽  
Author(s):  
Nicolas Roth ◽  
Johanna Zilliacus ◽  
Anna Beronius
Keyword(s):  
Risk Assessment ◽  
Methodological Quality ◽  
Online Survey ◽  
Human Health Risk ◽  
Reporting Quality ◽  
Test System ◽  
Toxicity Data ◽  
Hazard And Risk ◽  
Hazard And Risk Assessment

Efficient and successful integration of data generated from non-animal test methods must rely on reliable and relevant data. It is important therefore to develop tools and criteria that facilitate scientifically sound, structured, and transparent evaluation of reliability and relevance of in vitro toxicity data to efficiently inform regulatory hazard and risk assessment. The Science in Risk Assessment and Policy (SciRAP) initiative aims to promote such overarching goals. We present the work to develop and refine the SciRAP tool for evaluation of reliability and relevance of in vitro studies for incorporation on the SciRAP web-based platform (www.scirap.org). In the SciRAP approach, reliability evaluation is based on criteria for reporting quality and methodological quality, and is explicitly separated from relevance evaluation. The SciRAP in vitro tool (version 1.0) was tested and evaluated during an expert test round (April 2019-September 2020) on three in vitro studies by thirty-one experts from regulatory authorities, industry and academia from different geographical areas and with various degree of experience in in vitro research and/or human health risk assessment. In addition, the experts answered an online survey to collect their feedback about the general features and desired characteristics of the tool for further refinement. The SciRAP in vitro tool (version 2.0) was revised based on the outcome of the expert test round (study evaluation and online survey) and consists of 24 criteria for evaluating “reporting quality” (reliability), 16 criteria for “methodological quality” (reliability), and 4 items for evaluating relevance of in vitro studies. Participants were generally positive about the adequacy, flexibility, and user-friendliness of the tool. The expert test round outlined the need to (i) revise the formulation of certain criteria; (ii) provide new or revised accompanying guidance for reporting quality and methodological quality criteria in the “test compounds and controls,” “test system,” and “data collection and analysis” domains; and (iii) provide revised guidance for relevance items, as general measures to reduce inter-expert variability. The SciRAP in vitro tool allows for a structured and transparent evaluation of in vitro studies for use in regulatory hazard and risk assessment of chemicals.

Experimental Validation of Mass Balance Models for in Vitro Cell-Based Bioassays

2019 ◽  
Vol 54 (2) ◽  
pp. 1120-1127 ◽  
Author(s):  
Luise Henneberger ◽  
Marie Mühlenbrink ◽  
Daniel J. Heinrich ◽  
Alexandre Teixeira ◽  
Beate Nicol ◽  
...  
Keyword(s):  
Mass Balance ◽  
Experimental Validation ◽  
Mass Balance Models

scholarly journals Model-based contextualization of in vitro toxicity data quantitatively predicts in vivo drug response in patients

2016 ◽  
Vol 91 (2) ◽  
pp. 865-883 ◽  
Author(s):  
Christoph Thiel ◽  
Henrik Cordes ◽  
Isabel Conde ◽  
José Vicente Castell ◽  
Lars Mathias Blank ◽  
...  
Keyword(s):  
Drug Response ◽  
In Vitro Toxicity ◽  
Toxicity Data ◽  
Model Based

Toward More Useful In Vitro Toxicity Data with Measured Free Concentrations

2004 ◽  
Vol 38 (23) ◽  
pp. 6263-6270 ◽  
Author(s):  
Minne B. Heringa ◽  
Richard H. M. M. Schreurs ◽  
Frans Busser ◽  
Paul T. Van Der Saag ◽  
Bart Van Der Burg ◽  
...  
Keyword(s):  
In Vitro Toxicity ◽  
Toxicity Data
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