Toxicological evaluation of chemicals and pharmaceuticals

New chemical entities – how do we ensure that they are safe?

Chemicals are ubiquitous in our society, and we are exposed to them via chemical products, food, consumer products, the environment and pharmaceuticals. New chemical entities are being developed continuously, and this requires efficient ways to evaluate and ensure their human and environmental safety.

Tailor-made toxicological evaluations

For every request, we bring our broad competence and extensive experience to the table for an initial evaluation. Together with the client, we generate a plan for which toxicological information that has to be generated and evaluated – how, when and why. We are proficient in the entire process, from planning of synthesis to testing and registration of new chemical entities.

In silico, in vitro, in vivo, bioanalysis

Regardless of whether a chemical entity is to be used as a pharmaceutical or pesticide, or whether it’s to be used within a specific industry, we can provide several tools for toxicological evaluation. These tools can be utilized for studying the toxicological properties and evaluating possible risks during manufacturing as well as during and after use of the final product.

• Artificial intelligence (in silico) can predict outcomes in humans or environment, both in terms of toxicology and in terms of kinetic parameters (ADME; absorption, distribution, metabolism and excretion). In silico predictions can generate safety and ADME information at early stages in a drug or chemical development program, at a low cost and for large numbers of chemical structures.
• Cell models (in vitro) can generate valuable information on specific properties of the chemical and are suitable to run as follow-up to in silico predictions.
• Animal studies (in vivo) are being run with a specific focus on animal welfare (3R; Replace, Reduce, Refine). Our animal facilities and associated methods are certified according to GLP (Good Laboratory Practice). In vivo studies provide data for regulatory admissions and also support internal risk-benefit analyses for the company developing a drug or chemicals for the market. Histopathological evaluation is an important part of these studies.
• Bioanalytical methods are used for generating information on levels of both the chemical entity as well as of endogenous substances. Our analytical laboratories are also GLP-certified.