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.
ToxMinds assessed consumer exposures and risks associated with the release of volatile organic compounds, including benzene, formaldehyde and naphthalene from scented candles.
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.
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.
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.
ToxMinds supports a large, multinational cosmetic product manufacturer in prioritising new molecules for use in cosmetic applications from a consumer safety point of view.
ToxMinds supported a large multinational consumer product company in the context of an internal chemical safety review programme by developing standardised hazard assessments.
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.
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.
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