Ms. Namrata Jain

Ms. Avneet Kaur Suri

Dr. Monica Autiero

Using (Q)SAR and read across to evaluate the toxicological risks of data-poor drug impurities and extractables/leachables

Mutagenicity assessment of drug impurities according to the ICH M7 (R1) guideline and the role of expert review

The evaluation of the genotoxicity potential of drug impurities has been the focus of regulatory recommendations issued by the United States Food and Drug Administration (FDA, 2008), European Medicines Agency (EMA, 2006 and 2010), and International Conference for Harmonization (ICH, 2014, 2015). In 2017, the ICH M7 issued a revised guideline providing a framework for the assessment and control of mutagenic impurities in pharmaceuticals.

Inhalation exposure and risk assessment associated with the release of VOC, SVOC and particulates from scented candles

ToxMinds assessed consumer exposures and risks associated with the release of volatile organic compounds, including benzene, formaldehyde and naphthalene from scented candles.

Identification of hazards associated with non-intentionally added substances in a food contact polymer

ToxMinds was tasked by a petrochemical company to assess the toxicological hazard of and derive MRLs for non-intentionally added substances in a food contact polymer.

Development of permissible daily exposure levels of impurities present in pharmaceutical products

ToxMinds is a key resource to a major multinational biopharmaceutical company on the safety assessment of extractables & leachables and manufacturing impurities ending up in the medicinal product.

Human health risk assessment of a biocidal product line for due diligence purposes

ToxMinds supported the acquisition of a biocidal product line by a multinational consumer product company by demonstrating the safety of the products for children and adults under in-use conditions.

Feasibility screening of new molecules to be used in cosmetic applications

ToxMinds supports a large, multinational cosmetic product manufacturer in prioritising new molecules for use in cosmetic applications from a consumer safety point of view.

Evaluation of skin sensitisation potential of a class of functionalised chemicals on the basis of in silico, in vitro and in vivo data

ToxMinds assessed and evaluated the skin sensitisation potential of functionalised chemicals on the basis of in silico, in vitro and in vivo data.

Identification of safe exposure levels of ingredients used in cosmetic and consumer products

ToxMinds supported a large multinational consumer product company in the context of an internal chemical safety review programme by developing standardised hazard assessments.

QSAR Modelling

Application of in silico and TTC based decision tree for safety assessment of botanicals

Safety assessment of botanicals has always been a challenge, not only due to the difficulties in defining them analytically, but also due to data gaps in traditional toxicology endpoints.

Read-across – State of the art and next level!

In light of the limitations of existing non-animal based hazard assessment methodologies particularly for systemic endpoints, read-across is currently considered to be the most applicable strategy in the short- to medium-term in support of innovation.