Modelling approaches can be a valuable addition to market authorization dossiers

By Benoit Goussen, Section Head Ecological Modelling - Combining modelling methods with more traditional experimental methods can deliver important supplementary data when investigating the potential environmental risks of chemicals. Using modelling methods to better interpret experimental data allows for a more differentiated assessment of the real risks – and in critical cases, can help overcome possible restrictions to market authorization.

Combining modelling methods with experimental methods is a unique selling point at ibacon. We have scientists with solid experience in both disciplines working together under one roof to offer our clients new approaches. By cooperating closely, our experimental and modelling teams can provide clients with solutions to address the specific needs of individual chemicals using a combined set of tailored experiments and models specifically created for the purpose.

Traditional scientific experimental services test chemicals for their environmental effects and produce a set of standardized data. These traditional approaches allow environmental risks to be assessed and decisions to be taken as to whether the use of the chemical is environmentally safe. These experiments are carried out in accordance with internationally standardized and acknowledged guidelines – mostly from the OECD.

These traditional approaches are usually performed under optimal laboratory conditions that rarely represent the effect a chemical will have in a real-life usage situation. Indeed, these traditional experiments mostly run at constant exposure concentrations of a chemical in order to deliver standardization and results comparability. As a result, they do not account for real-life scenarios where the exposure concentrations can drop over the course of time. As a result, the traditional findings may overestimate the risks to the environment.

A particular strength of ibacon is that we can offer GLP experiments specifically designed to better inform modelling – thereby increasing the model’s robustness and its strength of predictability.

Modelling methods can offer a more realistic assessment of environmental effects by taking the results of experimental methods and extrapolating them based on realistic exposure concentrations. Models can be applied across a range of chemicals and environmental situations to provide greater understanding of complex systems and predict changes and the impact of alterations – such as the effect of different concentrations or on different timescales.

In the case of ecological modelling, where mathematical models of ecological processes are constructed and analysed, models can be analytic or simulation-based and are used to understand complex ecological processes and predict how real ecosystems might react to a perturbation. They are constructed in accordance with the laws of physics, mass conservation, and using biological information.

Whatever the chemical or the potential application situation in which the risk needs to be assessed, clients using modelling methods to support a market authorization dossier can obtain a more accurate understanding of environmental risks. This is especially the case in situations where experimental methods are reaching their limits or are particularly time- or resource- consuming. A robust modelling study to complement experimental results can make the difference between a chemical being granted market authorization or being rejected and obliged to undergo further testing.

Want more information about Ecological Modelling? Click on the download button below and find a detailed text.